SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY— 510(k) K131513

Name: FDA 510(k) clearance K131513
Creator: U.S. Food and Drug Administration
Published: 2014-07-11

Substantially Equivalent

Ritm Okb Zao

FDA 510(k) clearance K131513 for SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY, Substantially Equivalent on 2014-07-11. 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: 2013-05-28
Decision date: 2014-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taganrog, RU

Download summary PDF View on FDA.gov ↗

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