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 Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K885166
Device Name ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES
Applicant
Zmi Corp.
500 W. Cummings Park
Woburn,  MA  01801
Applicant Contact PAUL A LEVESQUE
Correspondent
Zmi Corp.
500 W. Cummings Park
Woburn,  MA  01801
Correspondent Contact PAUL A LEVESQUE
Regulation Number870.5550
Classification Product Code
DRO  
Date Received12/13/1988
Decision Date 05/01/1989
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
-
-