BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000— 510(k) K052625

Name: FDA 510(k) clearance K052625
Creator: U.S. Food and Drug Administration
Published: 2005-12-05

Substantially Equivalent

Bionicare Medical Technologies, Inc.

FDA 510(k) clearance K052625 for BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000, Substantially Equivalent on 2005-12-05. Applicant: Bionicare Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Bionicare Medical Technologies, Inc.
Product code: Code NYN
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2005-09-23
Decision date: 2005-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

Download summary PDF View on FDA.gov ↗

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