K182979 is an FDA 510(k) clearance for the IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on November 19, 2019, 389 days after receiving the submission on October 26, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K182979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2018 |
| Decision Date | November 19, 2019 |
| Days to Decision | 389 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |