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 Valve, Non-Rebreathing
510(k) Number K942468
Device Name PROTECTAIDE CPR PROTECTION PACK NO. 22100
Applicant
Protectaide, Inc.
605 White Hills Dr.
Rockwall,  TX  75087
Applicant Contact JAN DAVIS
Correspondent
Protectaide, Inc.
605 White Hills Dr.
Rockwall,  TX  75087
Correspondent Contact JAN DAVIS
Regulation Number868.5870
Classification Product Code
CBP  
Date Received05/25/1994
Decision Date 10/31/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-