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FDA 510(k)

SOMAVAC 100 Sustained Vacuum System

K-Number: K222856 · 2022-10-19

ApplicantSomavac Medical Solutions, Inc.
Decision Date2022-10-19
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 2022-10-19 under approval number K222856. 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 2022-10-19. It is manufactured by Somavac Medical Solutions, Inc.. The 510(k) number is K222856.

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

SOMAVAC 100 Sustained Vacuum System received FDA 510(k) clearance on 2022-10-19, under approval number K222856.

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 K231063SOMAVAC® 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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