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 K001788
Device Name ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200
Applicant
Erecords Enterprises
801 York Mills Rd.
Suite 314
Toronto,  CA
Applicant Contact ED GOSS
Correspondent
Erecords Enterprises
801 York Mills Rd.
Suite 314
Toronto,  CA
Correspondent Contact ED GOSS
Regulation Number870.1875
Classification Product Code
DQD  
Date Received06/13/2000
Decision Date 11/03/2000
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
-
-