BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000— 510(k) K971437

Name: FDA 510(k) clearance K971437
Creator: U.S. Food and Drug Administration
Published: 1997-07-22

Substantially Equivalent

Murray Electronics

FDA 510(k) clearance K971437 for BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000, Substantially Equivalent on 1997-07-22. Applicant: Murray Electronics. Device class: 2.

Clearance details

Applicant: Murray Electronics
Product code: Code NYN
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1997-04-18
Decision date: 1997-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hunt Valley, MD, US

Download summary PDF View on FDA.gov ↗

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