The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Patient Monitors Various Models.
| Device ID | K151812 |
| 510k Number | K151812 |
| Device Name: | PATIENT MONITORS VARIOUS MODELS |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN ROAD Andover, MA 03104 -1099 |
| Contact | Mary Kruitwagen |
| Correspondent | Mary Kruitwagen PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN ROAD Andover, MA 03104 -1099 |
| Product Code | MHX |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXQ |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-02 |
| Decision Date | 2016-01-26 |
| Summary: | summary |