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FDA 510(k)

MEDGEM

K-Number: K021605 · 2002-06-14

ApplicantHealthetech, Inc.
Decision Date2002-06-14
Product CodeBZL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDGEM is the device name listed in this FDA 510(k) record. The listed applicant is Healthetech, Inc.. It received FDA 510(k) clearance on 2002-06-14 under 510(k) number K021605. The device is classified under product code BZL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDGEM?

MEDGEM is a medical device that received FDA 510(k) clearance on 2002-06-14. The listed applicant is Healthetech, Inc.. The 510(k) number is K021605.

When did MEDGEM receive FDA 510(k) clearance?

MEDGEM received FDA 510(k) clearance on 2002-06-14, under 510(k) number K021605.

Who is the listed applicant for MEDGEM?

The FDA 510(k) record lists Healthetech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDGEM?

The FDA product code for MEDGEM is BZL.

Related Clinical Trials

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Other records listing Healthetech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K010577BODYGEM, MODEL HB211

Related Devices (Code: BZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200076Breezing MedTf Health Co.K190561NICU V'02Cosmed Nordic ApsK110810ANASCIENT BREATH MONITORInvoy Technologies, LLCK093080METAPHOR METABOLIC MONITORTreymed, Inc.K071533FITMATE SERIESCosmed SrlK070858EXPRESS SERIESMedical Graphics Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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