INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
FDA 510(k) clearance K131872 · decided 2013-10-17
Clearance details
- K-number
- K131872
- Device name
- INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Decision
- Substantially Equivalent
- Date received
- 2013-06-24
- Decision date
- 2013-10-17
- Days to decision
- 115 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boeblingen, Baden-Wuerttemberg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IntelliVue Patient Monitor MX500. Product Number: 866064. recall (Z-0864-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue Patient Monitor MX550. Product Number: 866066. recall (Z-0865-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and order recall (Z-0020-2025) | Philips North America Llc | 2024-10-04 |
| IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 recall (Z-3249-2024) | Philips North America | 2024-09-25 |