IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable
FDA 510(k) clearance K171801 · decided 2017-10-06
Clearance details
- K-number
- K171801
- Device name
- IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2017-06-16
- Decision date
- 2017-10-06
- Days to decision
- 112 days
- Clearance type
- Abbreviated
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boeblingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IntelliVue Multi-Measurement Module X3. Product Number: 867030. recall (Z-0860-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue Patient Monitor MX100. Product Number: 867033. recall (Z-0861-2026) | Philips North America Llc | 2025-12-02 |
| IntelliVue X3 Patient Monitor. recall (Z-1315-2018) | Philips Electronics North America Corporation | 2018-04-06 |
| Philips Network Firewall (Cisco ASA 5506), Model # 867098 recall (Z-0850-2018) | Philips Electronics North America Corporation | 2018-03-03 |