The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Vital Signs Monitor.
| Device ID | K131818 |
| 510k Number | K131818 |
| Device Name: | VITAL SIGNS MONITOR |
| Classification | Oximeter |
| Applicant | EDAN INSTRUMENTS, INC. EQUIPMENTS PARK, NANHAI RD 1019 NO. SHEKOU NANSHAN Shenzhen, CN 518067 |
| Contact | Queena Chen |
| Correspondent | Queena Chen EDAN INSTRUMENTS, INC. EQUIPMENTS PARK, NANHAI RD 1019 NO. SHEKOU NANSHAN Shenzhen, CN 518067 |
| Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-20 |
| Decision Date | 2013-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944413807808 | K131818 | 000 |
| 06944413800786 | K131818 | 000 |
| 06944413805316 | K131818 | 000 |
| 06944413805354 | K131818 | 000 |
| 06944413805378 | K131818 | 000 |
| 06944413805767 | K131818 | 000 |
| 06944413805774 | K131818 | 000 |
| 06944413806672 | K131818 | 000 |
| 06944413806689 | K131818 | 000 |
| 06944413807716 | K131818 | 000 |
| 06944413800618 | K131818 | 000 |