WALKCARE P200 SYSTEM— 510(k) K973592

Name: FDA 510(k) clearance K973592
Creator: U.S. Food and Drug Administration
Published: 1999-05-20

Substantially Equivalent

A.Stein - Regulatory Affairs Consulting

FDA 510(k) clearance K973592 for WALKCARE P200 SYSTEM, Substantially Equivalent on 1999-05-20. Applicant: A.Stein - Regulatory Affairs Consulting. Device class: 2.

Clearance details

Applicant: A.Stein - Regulatory Affairs Consulting
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 1997-09-22
Decision date: 1999-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ginot Shomron 44853, IL

Download summary PDF View on FDA.gov ↗

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