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 K162589
Device Name Adscope 658 Electronic Stethoscope
Applicant
American Diagnostic Corp.
55 Commerce Dr.
Hauppauge,  NY  11788
Applicant Contact Michael Falco
Correspondent
American Diagnostic Corp.
55 Commerce Dr.
Hauppauge,  NY  11788
Correspondent Contact Michael Falco
Regulation Number870.1875
Classification Product Code
DQD  
Date Received09/16/2016
Decision Date 03/10/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-