The following data is part of a premarket notification filed by Edan Instruments Inc with the FDA for Vital Signs Monitor.
| Device ID | K120144 |
| 510k Number | K120144 |
| Device Name: | VITAL SIGNS MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | EDAN INSTRUMENTS INC 3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK Shenzhen, CN 518067 |
| Contact | Randy Jiang |
| Correspondent | Randy Jiang EDAN INSTRUMENTS INC 3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK Shenzhen, CN 518067 |
| Product Code | DXN |
| Subsequent Product Code | DQA |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-18 |
| Decision Date | 2012-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B632MDB01005 | K120144 | 000 |