Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Spirometer, Diagnostic
510(k) Number K213872
Device Name ComPAS2
Applicant
Morgan Scientific, Inc.
151 Essex Street STE 8
Haverhill,  MA  01832
Applicant Contact Deborah Cornish
Correspondent
Morgan Scientific, Inc.
151 Essex Street STE 8
Haverhill,  MA  01832
Correspondent Contact Deborah Cornish
Regulation Number868.1840
Classification Product Code
BZG  
Date Received12/13/2021
Decision Date 07/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-