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, Enflurane, Gaseous-Phase (Anesthetic Concentration)
510(k) Number K931439
Device Name OHMEDA MODEL 5330 ANESTHETIC MONITOR
Applicant
Ohmeda Medical
1315 W. Louisville Dr.
Louisville,  CO  80027
Applicant Contact KEVIN MORNINGSTAR
Correspondent
Ohmeda Medical
1315 W. Louisville Dr.
Louisville,  CO  80027
Correspondent Contact KEVIN MORNINGSTAR
Regulation Number868.1500
Classification Product Code
CBQ  
Date Received03/22/1993
Decision Date 10/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-