DigiDop DD-301
DigiDop DD-301 is a Class II device made by Newman Medical, cleared under FDA 510(k) K090465 on 8 Apr 2009 and listed in FDA GUDID since 25 Jun 2021 (UDI-DI 00852785008876), active as of 22 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 | Number00852785008876 | Date25 Jun 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK090465 | Date8 Apr 2009 | StatusActive |
Official records
- AccessGUDID record 00852785008876
- FDA 510(k) database K090465
Across registries
- FDA 510(k) K090465 decided 8 Apr 2009 Active
- FDA GUDID UDI-DI 00852785008876 listed 25 Jun 2021 Listed
Timeline
- Cleared FDA 510(k) K090465
- Listed FDA GUDID 00852785008876
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DigiDop
- Generic name
- Foetal Doppler system
- Model / Ref / Catalog
- DD-301
- Primary DI / UDI-DI
- 00852785008876
- 510(k) Number
- FDA product code
- LXE, JAF
- GMDN term
- Foetal Doppler system
- Device class
- Class II
- Regulation number
- 884.2660, 892.1540
- GUDID distribution status
- In Commercial Distribution
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