The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Patient Monitor.
Device ID | K202336 |
510k Number | K202336 |
Device Name: | Patient Monitor |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122 |
Contact | Alice Yang |
Correspondent | Alice Yang Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122 |
Product Code | MHX |
Subsequent Product Code | BZQ |
Subsequent Product Code | CBQ |
Subsequent Product Code | CBR |
Subsequent Product Code | CBS |
Subsequent Product Code | CCK |
Subsequent Product Code | CCL |
Subsequent Product Code | DPS |
Subsequent Product Code | DQA |
Subsequent Product Code | DRT |
Subsequent Product Code | DSI |
Subsequent Product Code | DSK |
Subsequent Product Code | DXN |
Subsequent Product Code | FLL |
Subsequent Product Code | MLD |
Subsequent Product Code | NHO |
Subsequent Product Code | NHP |
Subsequent Product Code | NHQ |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-17 |
Decision Date | 2021-01-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PATIENT MONITOR 74564296 1942340 Live/Registered |
Brown, Frank L. 1994-08-22 |