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 mask, oxygen, non-rebreathing
510(k) Number K970688
Device Name POCKET RESCUE
Applicant
CHEEN HOUNG ENT. CO. LTD.
23 ALLEY 11 LANE 65 SAN DREEN
STREET
TAIPEI (SHULIN),  TW 23805
Applicant Contact JAY WANG
Correspondent
CHEEN HOUNG ENT. CO. LTD.
23 ALLEY 11 LANE 65 SAN DREEN
STREET
TAIPEI (SHULIN),  TW 23805
Correspondent Contact JAY WANG
Regulation Number868.5570
Classification Product Code
KGB  
Date Received02/25/1997
Decision Date 09/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-