The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Physiological Monitor, Patient Monitor.
| Device ID | K113441 |
| 510k Number | K113441 |
| Device Name: | PHYSIOLOGICAL MONITOR, PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Contact | Jens-peter Seher |
| Correspondent | Jens-peter Seher PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, 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 | 2011-11-21 |
| Decision Date | 2012-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838021563 | K113441 | 000 |
| 20884838071340 | K113441 | 000 |
| 20884838071388 | K113441 | 000 |
| 20884838071401 | K113441 | 000 |
| 20884838071425 | K113441 | 000 |
| 20884838071432 | K113441 | 000 |
| 20884838071449 | K113441 | 000 |
| 20884838071456 | K113441 | 000 |
| 20884838071463 | K113441 | 000 |
| 20884838071319 | K113441 | 000 |