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Fridababy WT701

by Raiing Medical Company

Fridababy WT701 is a Class II device made by Raiing Medical Company, cleared under FDA 510(k) K132761 on 8 Jul 2014 and listed in FDA GUDID since 27 Sep 2016 (UDI-DI 06957324290003), 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) K132761

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 Number06957324290003 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132761 Date8 Jul 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132761 decided 8 Jul 2014 Active
  • FDA GUDID UDI-DI 06957324290003 listed 27 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132761
  2. Listed FDA GUDID 06957324290003

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fridababy
Generic name
Continuous electronic patient thermometer, battery-powered
Model / reference
WT701
Primary DI / UDI-DI
06957324290003
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
Sterilisation method
Liquid Chemical

Similar devices

Other devices filed under FDA product code FLL (Thermometer, Electronic, Clinical).

Other devices from Raiing Medical Company

See all devices from Raiing Medical Company →

Properties

  • Sterilise before use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)