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 K940630
Device Name 503 MAXI COMPRESSOR
Applicant
Medical Industries America, Inc.
2879 R Ave.
Adel,  IA  50003
Applicant Contact MARK D HEBENSTREIT
Correspondent
Medical Industries America, Inc.
2879 R Ave.
Adel,  IA  50003
Correspondent Contact MARK D HEBENSTREIT
Regulation Number868.6250
Classification Product Code
BTI  
Date Received02/14/1994
Decision Date 02/21/1995
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
-
-