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 Vaporizer, Anesthesia, Non-Heated
510(k) Number K172702
Device Name Tec 820, Tec 850
Applicant
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, PO Box 7550
Madison,  WI  53707 -7550
Applicant Contact Trishia Mercier
Correspondent
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, PO Box 7550
Madison,  WI  53707 -7550
Correspondent Contact Trishia Mercier
Regulation Number868.5880
Classification Product Code
CAD  
Date Received09/07/2017
Decision Date 01/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-