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 K843446
Device Name DIGITAL SPHYGMOMANOMETER BP-2500
Applicant
Pollenex Associated Mills, Inc.
111 N. Canal St.
Chicago,  IL  60606
Applicant Contact GEORGE J CHIAMES
Correspondent
Pollenex Associated Mills, Inc.
111 N. Canal St.
Chicago,  IL  60606
Correspondent Contact GEORGE J CHIAMES
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/05/1984
Decision Date 05/15/1985
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
-
-