MEDGEM— 510(k) K021605

Substantially Equivalent

Healthetech, Inc.

FDA 510(k) clearance K021605 for MEDGEM, Substantially Equivalent on 2002-06-14. Applicant: Healthetech, Inc.. Device class: 2.

Clearance details

Applicant: Healthetech, Inc.
Product code: Code BZL
Device class: Class 2
Regulation: 21 CFR 868.1730
Advisory panel: Anesthesiology
Date received: 2002-05-16
Decision date: 2002-06-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

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