SCENAR, MODEL 10— 510(k) K092117

Substantially Equivalent

Ritm Okb Zao

FDA 510(k) clearance K092117 for SCENAR, MODEL 10, Substantially Equivalent on 2010-05-28. Applicant: Ritm Okb Zao. Device class: 2.

Clearance details

Applicant: Ritm Okb Zao
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2009-07-14
Decision date: 2010-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taganrog, RU

Download summary PDF View on FDA.gov ↗

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