COMPAS

Spirometer, Diagnostic

MORGAN SCIENTIFIC, INC.

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

Pre-market Notification Details

• Device ID: K021200
• 510k Number: K021200
• Device Name: COMPAS
• Classification: Spirometer, Diagnostic
• Applicant: MORGAN SCIENTIFIC, INC. 151 ESSEX ST. Haverhill, MA 01832
• Contact: Patrick F Morgan
• Correspondent: Patrick F Morgan; MORGAN SCIENTIFIC, INC. 151 ESSEX ST. Haverhill, MA 01832
• Product Code: BZG
• CFR Regulation Number: 868.1840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-04-16
• Decision Date: 2002-10-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851845007033	K021200	000