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FDA 510(k)

BODYGEM, MODEL HB211

K-Number: K010577 · 2002-01-10

ApplicantHealthetech, Inc.
Decision Date2002-01-10
Product CodeBZL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BODYGEM, MODEL HB211 is the device name listed in this FDA 510(k) record. The listed applicant is Healthetech, Inc.. It received FDA 510(k) clearance on 2002-01-10 under 510(k) number K010577. 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 BODYGEM, MODEL HB211?

BODYGEM, MODEL HB211 is a medical device that received FDA 510(k) clearance on 2002-01-10. The listed applicant is Healthetech, Inc.. The 510(k) number is K010577.

When did BODYGEM, MODEL HB211 receive FDA 510(k) clearance?

BODYGEM, MODEL HB211 received FDA 510(k) clearance on 2002-01-10, under 510(k) number K010577.

Who is the listed applicant for BODYGEM, MODEL HB211?

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 BODYGEM, MODEL HB211?

The FDA product code for BODYGEM, MODEL HB211 is BZL.

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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.

K021605MEDGEM

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.

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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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