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 plethysmograph, impedance
510(k) Number K191697
Device Name Cardiac Monitor 1500
Applicant
Zynex Medical, Inc.
9995 Maroon Circle
Englewood,  CO  80112
Applicant Contact Thomas Sandgaard
Correspondent
Zynex Medical, Inc.
9995 Maroon Circle
Englewood,  CO  80112
Correspondent Contact Thomas Sandgaard
Regulation Number870.2770
Classification Product Code
DSB  
Subsequent Product Codes
DQA   FLL  
Date Received06/25/2019
Decision Date 02/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-