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 K875160
Device Name RIGEL MODEL MULTICARE 409
Applicant
Rigel Medical Electronics, Inc.
250 Camino Alto
Mill Valley,  CA  94941
Applicant Contact MICHAEL E FEWER
Correspondent
Rigel Medical Electronics, Inc.
250 Camino Alto
Mill Valley,  CA  94941
Correspondent Contact MICHAEL E FEWER
Regulation Number870.2300
Classification Product Code
DRT  
Date Received12/15/1987
Decision Date 06/28/1988
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
-
-