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, Manual
510(k) Number K882324
Device Name STETH-SHIELD ACCESSORY TO A STETHOSCOPE
Applicant
Steth-Shield, Inc.
1360 Goodyear Blvd.
Akron,  OH  44305
Applicant Contact KENNETH R TURNER
Correspondent
Steth-Shield, Inc.
1360 Goodyear Blvd.
Akron,  OH  44305
Correspondent Contact KENNETH R TURNER
Regulation Number870.1875
Classification Product Code
LDE  
Date Received06/06/1988
Decision Date 07/18/1988
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
-
-