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 Compressor, Air, Portable
510(k) Number K945478
Device Name AM-50 AEROSOL/MEDICATION AIR COMPRESSOR
Applicant
Preferred Medical Supply, Inc.
1574 Kenmore Ave.
Buffalo,  NY  14216
Applicant Contact MARC SEPANSKI
Correspondent
Preferred Medical Supply, Inc.
1574 Kenmore Ave.
Buffalo,  NY  14216
Correspondent Contact MARC SEPANSKI
Regulation Number868.6250
Classification Product Code
BTI  
Date Received11/08/1994
Decision Date 09/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-