The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Vital Signs Monitor.
| Device ID | K180380 |
| 510k Number | K180380 |
| Device Name: | Vital Signs Monitor |
| Classification | Oximeter |
| Applicant | Edan Instruments, Inc. #15 Jinhui Road,Jinsha Community Kengzi Sub-District Pingshan District Shenzhen, CN 518122 |
| Contact | Alice Yang |
| Correspondent | Doug Worth Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, CA 94089 |
| Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-12 |
| Decision Date | 2018-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944413808812 | K180380 | 000 |