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FDA 510(k)

SOMAVAC Device

K-Number: K180606 · 2018-05-31

Decision Date2018-05-31
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOMAVAC Device is the device name listed in this FDA 510(k) record. The listed applicant is Somavac Medical Solutions, Inc.. It received FDA 510(k) clearance on 2018-05-31 under 510(k) number K180606. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMAVAC Device?

SOMAVAC Device is a medical device that received FDA 510(k) clearance on 2018-05-31. The listed applicant is Somavac Medical Solutions, Inc.. The 510(k) number is K180606.

When did SOMAVAC Device receive FDA 510(k) clearance?

SOMAVAC Device received FDA 510(k) clearance on 2018-05-31, under 510(k) number K180606.

Who is the listed applicant for SOMAVAC Device?

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

What is the FDA product code for SOMAVAC Device?

The FDA product code for SOMAVAC Device is BTA.

Other records listing Somavac Medical Solutions, 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.

Related Devices (Code: BTA)

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.

Official Source

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