Soteria Bed Barrier

510(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

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

Device ID	K201876
510k Number	K201876
Device Name:	Soteria Bed Barrier
Classification	510(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
Contact	Bruce Rippe
Correspondent	Bruce Rippe Trinity Guardion 4 S Park Ave Ste 204 Batesville, IN 47006
Product Code	QTV
CFR Regulation Number	510(k) Premarket Notification [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2020-07-07
Decision Date	2022-09-01