• 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 K150930
Device Name Deployable Oxygen Generation System-Smaill (DOGS-S)
AirSep Corporation
260 Creekside Drive
Buffalo,  NY  14228
Applicant Contact Peter Weisenborn
AirSep Corporation
260 Creekside Drive
Buffalo,  NY  14228
Correspondent Contact Ted Vlahopoulos
Regulation Number868.5440
Classification Product Code
Date Received04/06/2015
Decision Date 12/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No