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 Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K012451
Device Name PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246
Applicant
Welch Allyn Protocol, Inc.
8500 SW Creekside Place
Beaverton,  OR  97008 -7107
Applicant Contact DONALD M ABBEY
Correspondent
Welch Allyn Protocol, Inc.
8500 SW Creekside Place
Beaverton,  OR  97008 -7107
Correspondent Contact DONALD M ABBEY
Regulation Number870.2300
Classification Product Code
DRT  
Date Received08/01/2001
Decision Date 08/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-