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

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 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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