The following data is part of a premarket notification filed by Philips Medical Systems Nederlands B.v. with the FDA for Philips Hemodynamic Application R1.0.
| Device ID | K181311 |
| 510k Number | K181311 |
| Device Name: | Philips Hemodynamic Application R1.0 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Philips Medical Systems Nederlands B.V. Veenpluis 4-6 Best, NL 5684pc |
| Contact | Owen Callaghan |
| Correspondent | Owen Callaghan Philips Medical Systems Nederlands B.V. Veenpluis 4-6 Best, NL 5684pc |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-17 |
| Decision Date | 2018-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838084544 | K181311 | 000 |