• 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 K893557
Device Name ADAM (ACOUSTICAL DEVICE FOR ANATOMICAL MONITORING)
Applicant
Medical Monitors, Inc.
3007 Alabama Ave. N.
Fort Payne,  AL  35967
Applicant Contact GLYNN W ODOM
Correspondent
Medical Monitors, Inc.
3007 Alabama Ave. N.
Fort Payne,  AL  35967
Correspondent Contact GLYNN W ODOM
Regulation Number870.1875
Classification Product Code
DQD  
Date Received05/08/1989
Decision Date 03/19/1990
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
-
-