510(k) Clearance

Italian translation: Autorizzazione 510k

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:510(k) Clearance
Italian translation:Autorizzazione 510k
Entered by: PLR TRADUZIO (X)

22:38 Apr 29, 2014
English to Italian translations [PRO]
Tech/Engineering - Medical: Pharmaceuticals
English term or phrase: 510(k) Clearance
XXX was launched in February 2013 as an extension to the current YYY product family.
Other devices in the YYY family have 510(k) Clearance with the U.S. Food and Drug Administration, and we introduced XXX on the basis of a Note to File.

Si tratta di una campagna di richiamo su un prodotto per l'incontinenza fecale difettoso. Credo che questo 510(k) sia una sorta di dichiarazione, qualcosa che ha a che fare con l'FDA statunitense.
babi
Local time: 20:42
Autorizzazione 510k
Explanation:
http://www.businesswire.com/news/home/20110314006395/it/#.U2...
Selected response from:

PLR TRADUZIO (X)
Italy
Local time: 20:42
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2Autorizzazione 510k
PLR TRADUZIO (X)
3 +1approvazione FDA 510(k)
Elisa Brambilla
3notifica pre-commercializzazione 510(k)
angela manitto


  

Answers


10 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
510(k) clearance
Autorizzazione 510k


Explanation:
http://www.businesswire.com/news/home/20110314006395/it/#.U2...

PLR TRADUZIO (X)
Italy
Local time: 20:42
Specializes in field
Native speaker of: Native in ItalianItalian, Native in FrenchFrench
PRO pts in category: 79
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  Federica Borgini
7 hrs
  -> Grazie Federica

agree  Danila Moro
16 hrs
  -> Grazie Danilac
Login to enter a peer comment (or grade)

10 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
510(k) clearance
approvazione FDA 510(k)


Explanation:



    Reference: http://www.businesswire.com/news/home/20140317005900/it/#.U2...
Elisa Brambilla
Italy
Local time: 20:42
Native speaker of: Italian

Peer comments on this answer (and responses from the answerer)
agree  Danila Moro
6 hrs
  -> Grazie Danila!
Login to enter a peer comment (or grade)

23 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
510(k) clearance
notifica pre-commercializzazione 510(k)


Explanation:
Ho trovato questa spiegazione nel sito ufficiale FDA, dove la 510(k) viene anche chiamata Premarket Notification o PMN.

--------------------------------------------------
Note added at 23 ore (2014-04-30 22:10:30 GMT)
--------------------------------------------------

http://www.fda.gov/medicaldevices/productsandmedicalprocedur...

scusate, link corretto


    Reference: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
angela manitto
United States
Local time: 14:42
Native speaker of: Italian
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