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 Stethoscope, Electronic
510(k) Number K870810
Device Name DORCHES(TM) LIFESOUND(TM)
Applicant
Centauri Manufacturing, Inc.
4416 Russell Rd.
Lynnwood,  WA  98037
Applicant Contact JOHN R THOMPSON
Correspondent
Centauri Manufacturing, Inc.
4416 Russell Rd.
Lynnwood,  WA  98037
Correspondent Contact JOHN R THOMPSON
Regulation Number870.1875
Classification Product Code
DQD  
Date Received03/03/1987
Decision Date 06/29/1987
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
-
-