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 Ventilatory Effort Recorder
510(k) Number K021176
Device Name COMPUMEDICS SOMTE SYSTEM
Applicant
COMPUMEDICS LIMITED
6740 RIVERVIEW TERRACE
MINNEAPOLIS,,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
COMPUMEDICS LIMITED
6740 RIVERVIEW TERRACE
MINNEAPOLIS,,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number868.2375
Classification Product Code
MNR  
Date Received04/12/2002
Decision Date 01/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-