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FDA 510(k)

SOMAVAC® 100 Sustained Vacuum System

K-Number: K231063 · 2023-05-12

ApplicantSomavac Medical Solutions, Inc.
Decision Date2023-05-12
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOMAVAC® 100 Sustained Vacuum System is a medical device manufactured by Somavac Medical Solutions, Inc.. It received FDA 510(k) clearance on 2023-05-12 under approval number K231063. 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® 100 Sustained Vacuum System?

SOMAVAC® 100 Sustained Vacuum System is a medical device that received FDA 510(k) clearance on 2023-05-12. It is manufactured by Somavac Medical Solutions, Inc.. The 510(k) number is K231063.

When was SOMAVAC® 100 Sustained Vacuum System approved by the FDA?

SOMAVAC® 100 Sustained Vacuum System received FDA 510(k) clearance on 2023-05-12, under approval number K231063.

What company makes SOMAVAC® 100 Sustained Vacuum System?

SOMAVAC® 100 Sustained Vacuum System is manufactured by Somavac Medical Solutions, Inc..

What is the FDA product code for SOMAVAC® 100 Sustained Vacuum System?

The FDA product code for SOMAVAC® 100 Sustained Vacuum System is BTA.

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Other Devices by Somavac Medical Solutions, Inc.

K180606SOMAVAC Device K222856SOMAVAC 100 Sustained Vacuum System

Related Devices (Code: BTA)

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Official Source

View on FDA Database →

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

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