Soteria Bed Barrier

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Trinity Guardion

The following data is part of a premarket notification filed by Trinity Guardion with the FDA for Soteria Bed Barrier.

Pre-market Notification Details

Device IDK201876
510k NumberK201876
Device Name:Soteria Bed Barrier
Classification510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
Applicant Trinity Guardion 4 S Park Ave Ste 204 Batesville,  IN  47006
ContactBruce Rippe
CorrespondentBruce Rippe
Trinity Guardion 4 S Park Ave Ste 204 Batesville,  IN  47006
Product CodeQTV
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-07
Decision Date2022-09-01

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