510(k) K243778
- Device
- Body Temperature Software (BTS)
- Applicant
- Fitbit, LLC
- 510(k) number
- K243778
- Product code
- QZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-13
- Date received
- 2024-12-09
- Regulation
- 880.2915
- Classification name
- Body Temperature Sensing Software
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Nathan Austin
- Address
- 215 Fremont St. San Francisco CA US 94105 94105
FDA Registration Numbers#
- 3009253624
Source Documents#
Other 510(k) Records For Product Code QZA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN230050 | Body Temperature Software (BTS) | Fitbit, LLC | 2023-12-15 |