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 Automated External Defibrillators (Non-Wearable)
510(k) Number K030898
Device Name MOBILE BATTERY SERVICE STATION (MBSS)
Applicant
Ad Elektronik GmbH
33 Steeplechase Dr.
Tunersville,  NJ  08012
Applicant Contact RICHARD TOOTCHEN
Correspondent
Ad Elektronik GmbH
33 Steeplechase Dr.
Tunersville,  NJ  08012
Correspondent Contact RICHARD TOOTCHEN
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received03/21/2003
Decision Date 08/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-