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 Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K951110
Device Name CARDIO SERV
Applicant
Hellige GmbH
Heinrich Von Stephan Strabe4
D7800 Freiburg Im Breisga,  DE
Applicant Contact KLAUS RUDOLF
Correspondent
Hellige GmbH
Heinrich Von Stephan Strabe4
D7800 Freiburg Im Breisga,  DE
Correspondent Contact KLAUS RUDOLF
Regulation Number870.5300
Classification Product Code
LDD  
Date Received03/10/1995
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-