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 K983796
Device Name 6004 NIBP MONITOR WITH TEMPERATURE
Applicant
Bci Intl., Inc.
N7 W22025 Johnson Rd.
Waukesha,  WI  53186
Applicant Contact DONALD J ALEXANDER
Correspondent
Bci Intl., Inc.
N7 W22025 Johnson Rd.
Waukesha,  WI  53186
Correspondent Contact DONALD J ALEXANDER
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/27/1998
Decision Date 01/22/1999
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
Recalls CDRH Recalls
-
-