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 Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
510(k) Number K963579
Device Name PACE-1A CARDIAC STIMULATOR
Applicant
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803 -2516
Applicant Contact AMY J LAFORTE, PH.D
Correspondent
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803 -2516
Correspondent Contact AMY J LAFORTE, PH.D
Regulation Number870.1750
Classification Product Code
JOQ  
Date Received09/06/1996
Decision Date 11/08/1996
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
-
-