The following data is part of a premarket notification filed by Goldway Us, Inc. with the FDA for Goldway Patient Monitor, Model # Ut4000f.
| Device ID | K021154 |
| 510k Number | K021154 |
| Device Name: | GOLDWAY PATIENT MONITOR, MODEL # UT4000F |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | GOLDWAY US, INC. 12 SOUTH FIRST STREET, SUITE 1205 San Jose, CA 95113 |
| Contact | Y. Justin Chen |
| Correspondent | Y. Justin Chen GOLDWAY US, INC. 12 SOUTH FIRST STREET, SUITE 1205 San Jose, CA 95113 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-10 |
| Decision Date | 2003-04-11 |