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FDA 510(k)

Soteria Bed Barrier

K-Number: K201876 · 2022-09-01

ApplicantTrinity Guardion
Decision Date2022-09-01
Product CodeQTV
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Soteria Bed Barrier is a medical device manufactured by Trinity Guardion. It received FDA 510(k) clearance on 2022-09-01 under approval number K201876. The device is classified under product code QTV. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Soteria Bed Barrier?

Soteria Bed Barrier is a medical device that received FDA 510(k) clearance on 2022-09-01. It is manufactured by Trinity Guardion. The 510(k) number is K201876.

When was Soteria Bed Barrier approved by the FDA?

Soteria Bed Barrier received FDA 510(k) clearance on 2022-09-01, under approval number K201876.

What company makes Soteria Bed Barrier?

Soteria Bed Barrier is manufactured by Trinity Guardion.

What is the FDA product code for Soteria Bed Barrier?

The FDA product code for Soteria Bed Barrier is QTV.

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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