K181311 is an FDA 510(k) clearance for the Philips Hemodynamic Application R1.0. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).
Submitted by Philips Medical Systems Nederlands B.V. (Best Noord-Brabant, NL). The FDA issued a Cleared decision on September 7, 2018, 113 days after receiving the submission on May 17, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K181311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2018 |
| Decision Date | September 07, 2018 |
| Days to Decision | 113 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |