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 the device name listed in this FDA 510(k) record. The listed applicant is Trinity Guardion. It received FDA 510(k) clearance on 2022-09-01 under 510(k) 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. The listed applicant is Trinity Guardion. The 510(k) number is K201876.
When did Soteria Bed Barrier receive FDA 510(k) clearance?
Soteria Bed Barrier received FDA 510(k) clearance on 2022-09-01, under 510(k) number K201876.
Who is the listed applicant for Soteria Bed Barrier?
The FDA 510(k) record lists Trinity Guardion as the applicant. This does not by itself establish the device manufacturer.
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.