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 K071397
Device Name DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES
Applicant
SUNRISE MEDICAL
100 DEVILBISS DR.
SOMERSET,  PA  15501
Applicant Contact JOSEPH E OLSAVSKY
Correspondent
SUNRISE MEDICAL
100 DEVILBISS DR.
SOMERSET,  PA  15501
Correspondent Contact JOSEPH E OLSAVSKY
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/21/2007
Decision Date 10/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-