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 K021200
Device Name COMPAS
Applicant
MORGAN SCIENTIFIC, INC.
151 ESSEX ST.
HAVERHILL,  MA  01832
Applicant Contact PATRICK F MORGAN
Correspondent
MORGAN SCIENTIFIC, INC.
151 ESSEX ST.
HAVERHILL,  MA  01832
Correspondent Contact PATRICK F MORGAN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received04/16/2002
Decision Date 10/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-