FDA 510(k)

SOMA

K-Number: K962725 · 1996-07-25

Decision Date1996-07-25

Product CodeHQY

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SOMA is the device name listed in this FDA 510(k) record. The listed applicant is Soma International , Ltd.. It received FDA 510(k) clearance on 1996-07-25 under 510(k) number K962725. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMA?

SOMA is a medical device that received FDA 510(k) clearance on 1996-07-25. The listed applicant is Soma International , Ltd.. The 510(k) number is K962725.

When did SOMA receive FDA 510(k) clearance?

SOMA received FDA 510(k) clearance on 1996-07-25, under 510(k) number K962725.

Who is the listed applicant for SOMA?

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

What is the FDA product code for SOMA?

The FDA product code for SOMA is HQY.

Related PubMed Literature

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.

PMID: 29111623Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System. Final order.Federal register ()

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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.