510(k) K251670
- Device
- MAC 7 Resting ECG Analysis System
- Applicant
- Ge Medical Systems Information Technologies, Inc.
- 510(k) number
- K251670
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-26
- Date received
- 2025-05-30
- Regulation
- 870.2340
- Classification name
- Electrocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Yang Honghong
- Address
- 9900 Innovation Dr. Wauwatosa WI US 53226 53226
FDA Registration Numbers
- 3005877899
- 9710602
- 3023146633
- 1218950
- 3003174284
- 3032109181
- 1054713
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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