K230604 is an FDA 510(k) clearance for the IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030). 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 (Böblingen, DE). The FDA issued a Cleared decision on November 22, 2023, 264 days after receiving the submission on March 3, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K230604 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2023 |
| Decision Date | November 22, 2023 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| 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 |