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 Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K961644
Device Name MINIOX 3000 OXYGEN MONITOR
Applicant
Minesafety Appliances Co.
300 Walden Rd.
Mars,  PA  16066
Applicant Contact THOMAS P MCCLORY
Correspondent
Minesafety Appliances Co.
300 Walden Rd.
Mars,  PA  16066
Correspondent Contact THOMAS P MCCLORY
Regulation Number868.1720
Classification Product Code
CCL  
Date Received04/29/1996
Decision Date 07/25/1996
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
-
-