The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for M3046b Compact Portable Patient Monitors.
| Device ID | K052707 |
| 510k Number | K052707 |
| Device Name: | M3046B COMPACT PORTABLE PATIENT MONITORS |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Michael J Doyle |
| Correspondent | Michael J Doyle PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-29 |
| Decision Date | 2005-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838013292 | K052707 | 000 |
| 00884838013285 | K052707 | 000 |
| 00884838013278 | K052707 | 000 |
| 00884838013261 | K052707 | 000 |