Loss of Pulse Detection
FDA 510(k) clearance K242967 · decided 2025-02-25
Clearance details
- K-number
- K242967
- Device name
- Loss of Pulse Detection
- Applicant
- Fitbit
- Decision
- Substantially Equivalent
- Date received
- 2024-09-26
- Decision date
- 2025-02-25
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- SDY
- Device class
- 2
- Regulation number
- 870.2790
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.