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510(k) K201876

Device
Soteria Bed Barrier
Applicant
Trinity Guardion
510(k) number
K201876
Product code
QTV
Decision
Substantially Equivalent (SESE)
Decision date
2022-09-01
Date received
2020-07-07
Regulation
510(k) Premarket Notification
Classification name
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
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Bruce Rippe
Address
4 S Park Ave. Suite 204 Batesville IN US 47006 47006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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