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DigiDop DD-330R-D2W

by Newman Medical

DigiDop DD-330R-D2W 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 00852785008319), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K090465

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852785008319 UDI-DI Date25 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090465 Date8 Apr 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090465 decided 8 Apr 2009 Active
  • FDA GUDID UDI-DI 00852785008319 listed 25 Jun 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090465
  2. Listed FDA GUDID 00852785008319

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DigiDop
Generic name
Foetal Doppler system
Model / Ref / Catalog
DD-330R-D2W
Primary DI / UDI-DI
00852785008319
510(k) Number
FDA product code
LXE
GMDN term
Foetal Doppler system
Device class
Class II
Regulation number
884.2660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Foetal Doppler system

Cleared under the same submission (K090465)

and 8 more cleared under K090465

Similar devices in this category

Other devices filed under Foetal Doppler system.

Other devices from Newman Medical

  • Vasocuff Cuff-200

    Class II

  • simpleABI ABI-450CL

    Class II

  • DigiDop DD-330R-D2

    Class II

  • DigiDop DD-301

    Class II

See all devices from Newman Medical →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)