Dreambaby L320
Dreambaby L320 is a Class II device made by Tee-Zed Products, LLC, cleared under FDA 510(k) K103407 on 13 May 2011 and listed in FDA GUDID since 11 Oct 2019 (UDI-DI 00878931003205), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00878931003205 | Date11 Oct 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK103407 | Date13 May 2011 | StatusActive |
Official records
- AccessGUDID record 00878931003205
- FDA 510(k) database K103407
Across registries
- FDA 510(k) K103407 decided 13 May 2011 Active
- FDA GUDID UDI-DI 00878931003205 listed 11 Oct 2019 Listed
Timeline
- Cleared FDA 510(k) K103407
- Listed FDA GUDID 00878931003205
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dreambaby
- Generic name
- Continuous electronic patient thermometer, battery-powered
- Model / reference
- L320
- Primary DI / UDI-DI
- 00878931003205
- 510(k) Number
- FDA product code
- FLL
- GMDN term
- Continuous electronic patient thermometer, battery-powered
- Device class
- Class II
- Regulation number
- 880.2910
- GUDID distribution status
- In Commercial Distribution
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