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 K884405
Device Name FORTEC MI-150 DIGITAL BLOOD PRESSURE METER
Applicant
Nam Tai Electronic & Electrical Products, Ltd.
12/F. & 13/F., Century Centre
44-46 Hung To Rd., Kwun Tong
Kowloon, Hong Kong,  HK K72126
Applicant Contact REMEDIOS
Correspondent
Nam Tai Electronic & Electrical Products, Ltd.
12/F. & 13/F., Century Centre
44-46 Hung To Rd., Kwun Tong
Kowloon, Hong Kong,  HK K72126
Correspondent Contact REMEDIOS
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/20/1988
Decision Date 05/19/1989
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
-
-