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 K894562
Device Name ARBO H79P DISPOSABLE MONITORING ELECTRODES
Applicant
Arbo Medical, Inc.
35 Danbury Rd., Suite 2
Wilton,  CT  06897
Applicant Contact WAYNE SHOCKLOSS
Correspondent
Arbo Medical, Inc.
35 Danbury Rd., Suite 2
Wilton,  CT  06897
Correspondent Contact WAYNE SHOCKLOSS
Regulation Number870.2360
Classification Product Code
DRX  
Date Received07/21/1989
Decision Date 09/05/1989
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
-
-