The following data is part of a premarket notification filed by General Meditech, Inc. with the FDA for General Patient Monitors, Models: G3c/ G3d/ G3f/ G3g/ G3h.
| Device ID | K092970 |
| 510k Number | K092970 |
| Device Name: | GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GENERAL MEDITECH, INC. SUITE 5D, NO.19, LANE 999 ZHONGSHAN NO. 2 ROAD (S) Shanghai, CN 200030 |
| Contact | Lee Fu |
| Correspondent | Lee Fu GENERAL MEDITECH, INC. SUITE 5D, NO.19, LANE 999 ZHONGSHAN NO. 2 ROAD (S) Shanghai, CN 200030 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-25 |
| Decision Date | 2010-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938368100244 | K092970 | 000 |
| 06938368100077 | K092970 | 000 |
| 06938368100091 | K092970 | 000 |
| 06938368100114 | K092970 | 000 |
| 06938368100138 | K092970 | 000 |
| 06938368100152 | K092970 | 000 |
| 06938368100176 | K092970 | 000 |
| 06938368100190 | K092970 | 000 |
| 06938368100213 | K092970 | 000 |
| 06938368100237 | K092970 | 000 |
| 06938368100053 | K092970 | 000 |