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 K855015
Device Name NONINVASIVE TEMP. PACEMAKER NTP-1000
Applicant
Zmi Corp.
325 Vassar St.
Cambridge,  MA  02139
Applicant Contact ROLF S STUTZ
Correspondent
Zmi Corp.
325 Vassar St.
Cambridge,  MA  02139
Correspondent Contact ROLF S STUTZ
Regulation Number870.5550
Classification Product Code
DRO  
Date Received12/16/1985
Decision Date 03/31/1986
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
-
-