• 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 generator, oxygen, portable
510(k) Number K822789
Device Name ROOMATE II
Applicant
CRYOGENIC ASSOC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CRYOGENIC ASSOC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/15/1982
Decision Date 10/15/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-