The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Vital Signs Monitor:im3s, Im3as, Im3bs, Ihm3s.
Device ID | K202892 |
510k Number | K202892 |
Device Name: | Vital Signs Monitor:iM3s, IM3As, IM3Bs, IHM3s |
Classification | Monitor, Physiological, Patient (without 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 | MWI |
Subsequent Product Code | DQA |
Subsequent Product Code | DXN |
Subsequent Product Code | FLL |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-28 |
Decision Date | 2021-01-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06944413813465 | K202892 | 000 |
06944413813458 | K202892 | 000 |
06944413813441 | K202892 | 000 |
06944413812055 | K202892 | 000 |
06944413812048 | K202892 | 000 |
06944413811874 | K202892 | 000 |
06944413811171 | K202892 | 000 |