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 generator, oxygen, portable
510(k) Number K120566
Device Name O2PAK OXYGEN GENERATOR
Applicant
PACIFIC PRECISION PRODUCTS
9671 IRVINE CENTER DRIVE
IRVINE,  CA  92618
Applicant Contact GERALD WHITE
Correspondent
PACIFIC PRECISION PRODUCTS
9671 IRVINE CENTER DRIVE
IRVINE,  CA  92618
Correspondent Contact GERALD WHITE
Regulation Number868.5440
Classification Product Code
CAW  
Date Received02/27/2012
Decision Date 07/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
-
-