• 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 K941490
Device Name BLOOD PRESSURE METER MODEL NO. BPM888
Applicant
Integrated Display Technology, Ltd.
9c Kaiser Estate, Phase 1
41 Man Yue St.
Hunghom, Kowloon,  HK
Applicant Contact LEO NG
Correspondent
Integrated Display Technology, Ltd.
9c Kaiser Estate, Phase 1
41 Man Yue St.
Hunghom, Kowloon,  HK
Correspondent Contact LEO NG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/28/1994
Decision Date 11/29/1994
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
-
-