ComPAS2

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

Morgan Scientific, Inc.

The following data is part of a premarket notification filed by Morgan Scientific, Inc. with the FDA for Compas2.

Pre-market Notification Details

• Device ID: K213872
• 510k Number: K213872
• Device Name: ComPAS2
• 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: Morgan Scientific, Inc. 151 Essex Street STE 8 Haverhill, MA 01832
• Contact: Deborah Cornish
• Correspondent: Deborah Cornish; Morgan Scientific, Inc. 151 Essex Street STE 8 Haverhill, MA 01832
• Product Code: 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 &
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-12-13
• Decision Date: 2022-07-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851845007170	K213872	000
00851845007187	K213872	000