MAC 600 RESTING ECG ANALYSIS SYSTEM— 510(k) K103765
Substantially EquivalentGe Medical Systems Information Technologies, Inc.
FDA 510(k) clearance K103765 for MAC 600 RESTING ECG ANALYSIS SYSTEM, Substantially Equivalent on 2011-05-17. 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.