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 System, Network And Communication, Physiological Monitors
510(k) Number K132036
Device Name HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)
Applicant
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
800 Macarthur Blvd.
Mahwh,  NJ  07430
Applicant Contact RUSSELL OLSEN
Correspondent
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
800 Macarthur Blvd.
Mahwh,  NJ  07430
Correspondent Contact RUSSELL OLSEN
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
DPZ   DQA   DRQ   MHX  
Date Received07/01/2013
Decision Date 07/01/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-