Regulatory filing
K221774 (us_fda)
510(k) clearance for the Garmin ECG app (single-lead electrocardiogram); cleared 2023.
fda 510k · cleared · decided 2023-01-12
Machine-readable surfaces
- Markdown mirror: /regulatory-filings/fda-k221774-garmin-ecg.md
- JSON-LD: embedded in this page’s head
- REST API: /v1/filings/514f7831-3baa-4536-a199-ac68fa1ed4de
- Revision history: /regulatory-filings/fda-k221774-garmin-ecg/history
- Data documentation: /data
Key facts
- Jurisdiction
- us_fda
- Filing type
- fda 510k
- Status
- cleared
- Filing number
- K221774
- Filing date
- 2022-06-21
- Decision date
- 2023-01-12
- Verification posture
- verified
Applicant
Covered models (1)
Sources (1)
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Identity
514f7831-3baa-4536-a199-ac68fa1ed4de