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 System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K152770
Device Name ProBP 2400 Digital Blood Pressure Device
Applicant
MICROLIFE INTELLECTUAL PROPERTY GMBH
ESPENSTRASSE 139
WIDNAU,  CH 9443
Applicant Contact GERHARD FRICK
Correspondent
MDI CONSULTANTS, INC.
55 NORTHERN BLVD.
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D. GOLDSTEIN-FALK
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/25/2015
Decision Date 10/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-