The following data is part of a premarket notification filed by Goldway (us), Inc. with the FDA for Comen Multi-parameter Patient Monitor.
| Device ID | K112877 |
| 510k Number | K112877 |
| Device Name: | COMEN MULTI-PARAMETER PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | GOLDWAY (US), INC. 2600 MISSION STREET SUITE 100 San Marino, CA 91108 |
| Contact | Jimmy Wu |
| Correspondent | Jimmy Wu GOLDWAY (US), INC. 2600 MISSION STREET SUITE 100 San Marino, CA 91108 |
| Product Code | MWI |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2012-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945429085211 | K112877 | 000 |
| 06945429082548 | K112877 | 000 |
| 06945429000009 | K112877 | 000 |