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 Unit, Liquid-Oxygen, Portable
510(k) Number K013251
Device Name SPIRIT 300
Applicant
Caire, Inc.
3505 County Rd. 42 W.
Burnsville,  MN  55306
Applicant Contact ROGER BRIESE
Correspondent
Tuv Product Service, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact MARK JOB
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received09/28/2001
Decision Date 12/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-