MAC VU360 Resting ECG Analysis System— 510(k) K173830
Substantially EquivalentGe Medical Systems Information Technologies, Inc.
FDA 510(k) clearance K173830 for MAC VU360 Resting ECG Analysis System, Substantially Equivalent on 2018-09-18. Applicant: Ge Medical Systems Information Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies, Inc.
- Product code
- Code DPS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wauwatosa, WI, US
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Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
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 K173830
K-number listed on FDA's recall record- Z-2876-2026 — GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
- Z-0231-2026 — MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
- Z-0543-2021 — MAC VU360, Electrocardiograph
- Z-2060-2019 — MAC VU360, Model Number 2030360-001, Electrocardiograph
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173830.
Data sourced from openFDA. This site is unofficial and independent of the FDA.