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 analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K041956
Device Name EMG - ESSENTIAL GAS MODULE, MODEL M1013A
Applicant
DRAEGET MEDICAL AG & CO. KGAA
3135 Quarry Road
Telford,  PA  18969
Applicant Contact JAMES J BRENNAN
Correspondent
DRAEGET MEDICAL AG & CO. KGAA
3135 Quarry Road
Telford,  PA  18969
Correspondent Contact JAMES J BRENNAN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received07/21/2004
Decision Date 08/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-