The following data is part of a premarket notification filed by North-vision Tech. Inc. with the FDA for North-vision Multi-parameter Patient Monitor.
| Device ID | K173036 |
| 510k Number | K173036 |
| Device Name: | North-vision Multi-parameter Patient Monitor |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | North-vision Tech. Inc. 1st Fl., No.15, Gongye E. 2nd Rd., East Dist. Hsinchu City, TW 30075 |
| Contact | Albert Huang |
| Correspondent | Shin-ban Tsai Pan-America Hyperbarics, Inc. 3528 Robin Road Plano, TX 75075 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2018-12-21 |
| Summary: | summary |