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 Electrode, Electrocardiograph
510(k) Number K853939
Device Name ECG-ELECTRODE(SWAROMED)
Applicant
D. Swarovski & Co.
A-6112 Wattens
Austria,  AT
Applicant Contact SCHULER
Correspondent
D. Swarovski & Co.
A-6112 Wattens
Austria,  AT
Correspondent Contact SCHULER
Regulation Number870.2360
Classification Product Code
DRX  
Date Received09/24/1985
Decision Date 04/11/1986
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
-
-