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 K993410
Device Name DATES-OHMEDA AESTIVA SMARTVENT MRI
Applicant
DATEX-OHMEDA, INC.
OHMEDA DR.
P.O. BOX 7550
MADISON,  WI  53707 -7550
Applicant Contact DANIEL KOSEDNAR
Correspondent
DATEX-OHMEDA, INC.
OHMEDA DR.
P.O. BOX 7550
MADISON,  WI  53707 -7550
Correspondent Contact DANIEL KOSEDNAR
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received10/12/1999
Decision Date 04/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-