The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Patient Monitor: Resparray.
Device ID | K220308 |
510k Number | K220308 |
Device Name: | Patient Monitor: RespArray |
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 | Joan. Wei |
Correspondent | Joan. Wei Edan Instruments, Inc. #15 Jinhui Road,Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122 |
Product Code | MHX |
Subsequent Product Code | CCK |
Subsequent Product Code | DQA |
Subsequent Product Code | DRT |
Subsequent Product Code | DSB |
Subsequent Product Code | DSI |
Subsequent Product Code | DSK |
Subsequent Product Code | DXN |
Subsequent Product Code | FLL |
Subsequent Product Code | MLD |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-02-02 |
Decision Date | 2022-08-11 |