Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SOMAVAC Device

K-Number: K180606 · 2018-05-31

ApplicantSomavac Medical Solutions, Inc.
Decision Date2018-05-31
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOMAVAC Device is a medical device manufactured by Somavac Medical Solutions, Inc.. It received FDA 510(k) clearance on 2018-05-31 under approval 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. It is manufactured by Somavac Medical Solutions, Inc.. The 510(k) number is K180606.

When was SOMAVAC Device approved by the FDA?

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

What company makes SOMAVAC Device?

SOMAVAC Device is manufactured by Somavac Medical Solutions, Inc..

What is the FDA product code for SOMAVAC Device?

The FDA product code for SOMAVAC Device is BTA.

Other Devices by Somavac Medical Solutions, Inc.

K222856SOMAVAC 100 Sustained Vacuum System K231063SOMAVAC® 100 Sustained Vacuum System

Related Devices (Code: BTA)

K161002Aprima Smartesis Centesis PumpCook Incorporated K153663Vario 8/18/ciMedela AG K153459TACVACAthena Gtx K170533Model 330 Multifunction AspiratorZOLL Medical Corporation K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorTaidoc Technology Corporation K181667Thoraguard SystemCentese, Inc.

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.

↑