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 Gas-Machine, Anesthesia
510(k) Number K973985
Device Name AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
Applicant
DATEX-ENGSTROM, INC.
2 HIGHWOOD DR.
TEWKSBURY,  MA  01876
Applicant Contact JOEL KENT
Correspondent
DATEX-ENGSTROM, INC.
2 HIGHWOOD DR.
TEWKSBURY,  MA  01876
Correspondent Contact JOEL KENT
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received10/20/1997
Decision Date 10/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-