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 monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K182075
Device Name BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
Applicant
Shenzhen Mindray Bio-medical Electronics Co., LTD.
Mindray Building, Keji 12th Road South
Hi-tech Industrial Park, Nanshan
Shenzhen,  TW 518057
Applicant Contact Yanhong Bai
Correspondent
Shenzhen Mindray Bio-medical Electronics Co., LTD.
Mindray Building, Keji 12th Road South
Hi-tech Industrial Park, Nanshan
Shenzhen,  TW 518057
Correspondent Contact Yanhong Bai
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DQA   DRT   DSI   DSK   DXN  
FLL   MLD  
Date Received08/01/2018
Decision Date 12/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-