MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System— 510(k) K221321
Substantially EquivalentGe Medical Systems Information Technologies, Inc.
FDA 510(k) clearance K221321 for MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System, Substantially Equivalent on 2022-10-18. 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
Recent devices under product code DPS
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- K243540 — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
- K233810 — Portrait VSM
- K234130 — Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O
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 K221321
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221321.
Data sourced from openFDA. This site is unofficial and independent of the FDA.