The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd. with the FDA for M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000.
| Device ID | K100046 |
| 510k Number | K100046 |
| Device Name: | M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GUANGDONG BIOLIGHT MEDITECH CO., LTD. SUITE 5D, NO. 19, LANE 999 ZHONGSHAN ROAD (S-2) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong GUANGDONG BIOLIGHT MEDITECH CO., LTD. SUITE 5D, NO. 19, LANE 999 ZHONGSHAN ROAD (S-2) Shanghai, CN 200030 |
| Product Code | MHX |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FFL |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-08 |
| Decision Date | 2010-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932562310232 | K100046 | 000 |
| 06932562310164 | K100046 | 000 |
| 06932562310140 | K100046 | 000 |
| 06932562310133 | K100046 | 000 |
| 06932562310331 | K100046 | 000 |