• 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 K800764
Device Name DRAGER ORMC
Applicant
DRAEGER MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DRAEGER MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5330
Classification Product Code
BZR  
Date Received04/07/1980
Decision Date 04/29/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-