The following data is part of a premarket notification filed by Philips Medizin Systeme Boblingen Gmbh with the FDA for Intellivue Patient Monitor.
| Device ID | K113657 |
| 510k Number | K113657 |
| Device Name: | INTELLIVUE PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH HEWLETT-PACKARD-STR. 2 Boblingen, DE D-71034 |
| Contact | Manfred Stever |
| Correspondent | Manfred Stever PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH HEWLETT-PACKARD-STR. 2 Boblingen, DE D-71034 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-12 |
| Decision Date | 2012-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838011953 | K113657 | 000 |