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 Transducer, Blood-Pressure, Extravascular
510(k) Number K930888
Device Name WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM
Applicant
Ralin Medical, Inc.
8320 SW Nimbus Ave.
Bldg. 2
Beaverton,  OR  97005
Applicant Contact DONALD OWEN
Correspondent
Ralin Medical, Inc.
8320 SW Nimbus Ave.
Bldg. 2
Beaverton,  OR  97005
Correspondent Contact DONALD OWEN
Regulation Number870.2850
Classification Product Code
DRS  
Subsequent Product Code
DXH  
Date Received02/19/1993
Decision Date 07/21/1993
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
-
-