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 ventilator, non-continuous (respirator)
510(k) Number K100121
Device Name MODEL 300157 CPAP SYSTEM
Applicant
AEIOMED, INC.
1313 5TH STREET SE, STE 205
MINNEAPOLIS,  MN  55414
Applicant Contact DARIN BUSCH
Correspondent
AEIOMED, INC.
1313 5TH STREET SE, STE 205
MINNEAPOLIS,  MN  55414
Correspondent Contact DARIN BUSCH
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/15/2010
Decision Date 07/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-