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 Recorder, Magnetic Tape, Medical
510(k) Number K143067
Device Name Carnation Ambulatory Monitor
Applicant
Bardy Diagnostics, Inc.
17141 Vashon Highway, Sw.
Vashon Island,  WA  98070
Applicant Contact JON P. HUNT
Correspondent
Bardy Diagnostics, Inc.
17141 Vashon Highway, Sw.
Vashon Island,  WA  98070
Correspondent Contact JON P. HUNT
Regulation Number870.2800
Classification Product Code
DSH  
Date Received10/24/2014
Decision Date 12/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-