The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co. with the FDA for Panorama Patient Monitoring Network.
Device ID | K142601 |
510k Number | K142601 |
Device Name: | Panorama Patient Monitoring Network |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | Shenzhen Mindray Bio-Medical Electronics Co. Bldg. 9-13 , Baiwangxin High-Tech Industrial Park Biamang, Xili Town Nasham, CN 518108 |
Contact | Diane Arpino |
Correspondent | Diane Arpino Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd Bldg. 9-13, Baiwangxin High-Tech Industrial Park Biamang, Xili Town Nasham, CN 518108 |
Product Code | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-11 |
Decision Date | 2014-11-14 |
Summary: | summary |