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 mixer, breathing gases, anesthesia inhalation
510(k) Number K800905
Device Name SIEMENS-ELEMA AB O2-AIR MIXER 960
Applicant
SIEMENS ELEMA AB
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SIEMENS ELEMA AB
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5330
Classification Product Code
BZR  
Date Received04/21/1980
Decision Date 05/08/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-