STRESS HANDLER— 510(k) K936148

Name: FDA 510(k) clearance K936148
Creator: U.S. Food and Drug Administration
Published: 1994-04-21

Substantially Equivalent for Some Indications

Arocep Enterprises , Ltd.

FDA 510(k) clearance K936148 for STRESS HANDLER, Substantially Equivalent for Some Indications on 1994-04-21. Applicant: Arocep Enterprises , Ltd.. Device class: 1.

Clearance details

Applicant: Arocep Enterprises , Ltd.
Product code: Code LYG
Device class: Class 1
Regulation: 21 CFR 890.5660
Advisory panel: Physical Medicine
Date received: 1993-12-27
Decision date: 1994-04-21
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Brampton, Ontario, CA

Download summary PDF View on FDA.gov ↗

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