CareEvent inclusive of the CareEvent Mobile Application accessory— 510(k) K161164
Substantially EquivalentPhilips Medical Systems
FDA 510(k) clearance K161164 for CareEvent inclusive of the CareEvent Mobile Application accessory, Substantially Equivalent on 2016-06-24. Applicant: Philips Medical Systems. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems
- Product code
- Code MSX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Andover, MA, US
Recent devices under product code MSX
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Adverse events under product code MSX
product code MSX- Death
- 59
- Total
- 59
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K161164
K-number listed on FDA's recall record- Z-1387-2024 — CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
- Z-0731-2024 — (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424
- Z-0732-2024 — (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161164.
Data sourced from openFDA. This site is unofficial and independent of the FDA.