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 Computer, Blood-Pressure
510(k) Number K903900
Device Name SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.
Applicant
Ppg Hellige B.V.
D-7800 Freiburg
West Germany,  DE
Applicant Contact RUDOLF K HERZ
Correspondent
Ppg Hellige B.V.
D-7800 Freiburg
West Germany,  DE
Correspondent Contact RUDOLF K HERZ
Regulation Number870.1110
Classification Product Code
DSK  
Date Received08/23/1990
Decision Date 01/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-