Glossary entry (derived from question below)
English term or phrase:
(under) 510 (k) procedure
Russian translation:
успешно прошедшего разрешительную процедуру FDA (510k)/прошедшего перед выходом на рынок предварительную экспертизу (PMN = Premarket Notification)
Added to glossary by
Irina Semjonov
Aug 22, 2011 18:23
12 yrs ago
2 viewers *
English term
Germany
Double MA in different discipl. clusters
Native in: Russian 
Works in: German to Russian, Estonian to Russian, English to Russian, and 2 more.
(under) 510 (k) procedure
English to Russian
Tech/Engineering
Electronics / Elect Eng
Wellness-Geräte / Gesundheitstechnik
...use the electrode pads with CE mark or legally marketed in the US under 510 (k) procedure.
= используйте электродные контакты с маркировкой CE или легально проданные на рынке в США согласно ...?
Заранее благодарю за помощь!
= используйте электродные контакты с маркировкой CE или легально проданные на рынке в США согласно ...?
Заранее благодарю за помощь!
Proposed translations
(Russian)
| 3 +1 | успешно пройдя разрешительную процедуру FDA (510k) |
Igor Antipin
|
| 3 | см. ответ |
Helg
|
Proposed translations
+1
25 mins
Igor Antipin
Russian Federation
Russian Federation
Native in Russian
Russian Federation
PhD. 10+ years in technical translation
Native in: Russian (Variant: Standard-Russia)
Works in: English to Russian
Related KudoZ points
:
141
Selected
успешно пройдя разрешительную процедуру FDA (510k)
Цитата 1:
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).
Цитата 2:
(a) After review of a premarket notification, FDA will:
(1) Issue an order declaring the device to be substantially equivalent to a legally marketed predicate device;
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).
Цитата 2:
(a) After review of a premarket notification, FDA will:
(1) Issue an order declaring the device to be substantially equivalent to a legally marketed predicate device;
4 KudoZ points awarded for this answer.
Comment: "Спасибо! Может, несколько несправедливо выбрать данный ответ, данный позже, но мне очень помогли ссылки в ответе и объяснения в них. "
4 mins
см. ответ
отвечают критериям статьи (или раздела) 510 (k) закона США (требования к качеству продуктов питания, лекарственных и косметических средств)
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