The following data is part of a premarket notification filed by Goldway (us), Inc. with the FDA for Goldway Ut4000a Vital Signs Monitor.
| Device ID | K033988 |
| 510k Number | K033988 |
| Device Name: | GOLDWAY UT4000A VITAL SIGNS MONITOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | GOLDWAY (US), INC. 2600 MISSION STREET SUITE 100 San Marino, CA 91108 |
| Contact | Yingchao Xiao |
| Correspondent | Yingchao Xiao GOLDWAY (US), INC. 2600 MISSION STREET SUITE 100 San Marino, CA 91108 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-23 |
| Decision Date | 2004-02-25 |
| Summary: | summary |