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 Pump, Infusion
510(k) Number K090736
Device Name POWER INFUSER, MODEL M100B-3A
Applicant
ZOLL Medical Corporation
269 Mill Rd.
Chelmsford,  MA 
Applicant Contact EILEEN M BOYLE
Correspondent
ZOLL Medical Corporation
269 Mill Rd.
Chelmsford,  MA 
Correspondent Contact EILEEN M BOYLE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/19/2009
Decision Date 05/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-