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FDA 510(k)

HOLTAIN BODY COMPOSITION ANALYSER

K-Number: K891928 · 1989-09-22

ApplicantSeritex, Inc.
Decision Date1989-09-22
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTAIN BODY COMPOSITION ANALYSER is the device name listed in this FDA 510(k) record. The listed applicant is Seritex, Inc.. It received FDA 510(k) clearance on 1989-09-22 under 510(k) number K891928. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOLTAIN BODY COMPOSITION ANALYSER?

HOLTAIN BODY COMPOSITION ANALYSER is a medical device that received FDA 510(k) clearance on 1989-09-22. The listed applicant is Seritex, Inc.. The 510(k) number is K891928.

When did HOLTAIN BODY COMPOSITION ANALYSER receive FDA 510(k) clearance?

HOLTAIN BODY COMPOSITION ANALYSER received FDA 510(k) clearance on 1989-09-22, under 510(k) number K891928.

Who is the listed applicant for HOLTAIN BODY COMPOSITION ANALYSER?

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

What is the FDA product code for HOLTAIN BODY COMPOSITION ANALYSER?

The FDA product code for HOLTAIN BODY COMPOSITION ANALYSER is DSB.

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Related Devices (Code: DSB)

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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