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 Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K821384
Device Name EXERCISE ECG ELECTRODES, REUSABLE
Applicant
Respironics, Inc.
530 Seco Rd.
Monroeville,  PA  15146
Correspondent
Respironics, Inc.
530 Seco Rd.
Monroeville,  PA  15146
Regulation Number870.2910
Classification Product Code
DRG  
Date Received05/10/1982
Decision Date 06/17/1982
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
-
-