The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Suresigns Central.
| Device ID | K131032 |
| 510k Number | K131032 |
| Device Name: | PHILIPS SURESIGNS CENTRAL |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD Andover, MA 01810 |
| Contact | Mary Kruitwagen |
| Correspondent | Mary Kruitwagen PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD Andover, MA 01810 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-12 |
| Decision Date | 2013-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838039056 | K131032 | 000 |