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Unimed UC-60E-BT

by Unimed Medical Supplies, Inc.

Unimed UC-60E-BT is a Class II device made by Unimed Medical Supplies, Inc., cleared under FDA 510(k) K142832 on 6 Feb 2015 and listed in FDA GUDID since 16 Sep 2021 (UDI-DI 06945664858984), 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) K142832

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 Number06945664858984 UDI-DI Date16 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142832 Date6 Feb 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142832 decided 6 Feb 2015 Active
  • FDA GUDID UDI-DI 06945664858984 listed 16 Sep 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K142832
  2. Listed FDA GUDID 06945664858984

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Unimed
Generic name
Pulse oximeter, line-powered
Model / reference
UC-60E-BT
Primary DI / UDI-DI
06945664858984
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter, line-powered
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

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Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)