• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back To Search Results
Device Classification Name recorder, magnetic tape, medical
510(k) Number K113862
Device Name ZIO PATCH
Original Applicant
650 townsend street
suite 380
san francisco,  CA  94103
Original Contact michael righter
Regulation Number870.2800
Classification Product Code
Date Received12/30/2011
Decision Date 02/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Combination Product No