510(k) K242967
- Device
- Loss of Pulse Detection
- Applicant
- Fitbit
- 510(k) number
- K242967
- Product code
- SDY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-25
- Date received
- 2024-09-26
- Regulation
- 870.2790
- Classification name
- Loss Of Pulse Notification Software
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dinesh Puppala
- Address
- 215 Fremont St. San Francisco CA US 94105 94105
FDA Registration Numbers#
- 3009253624