The following data is part of a premarket notification filed by Shenzhen Comen Medical Instruments Co.,ltd. with the FDA for Multi-parameter Patient Monitor, Models C30.
| Device ID | K173454 |
| 510k Number | K173454 |
| Device Name: | Multi-parameter Patient Monitor, Models C30 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Shenzhen Comen Medical Instruments Co.,Ltd. South Of Floor 7, BLock 5 4th Industrial Area Of Nanyou, Nanshan District Shenzhen, CN 518052 |
| Contact | Hongbo Yan |
| Correspondent | Hongbo Yan Shenzhen Comen Medical Instruments Co.,Ltd. South Of Floor 7, BLock 5 4th Industrial Area Of Nanyou, Nanshan District Shenzhen, CN 518052 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-06 |
| Decision Date | 2018-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945429055566 | K173454 | 000 |