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Nonin 7600 TC-1

by Nonin Medical, Inc.

Nonin 7600 TC-1 is a Class II device made by Nonin Medical, Inc., cleared under FDA 510(k) K090807 on 30 Jun 2009 and listed in FDA GUDID since 3 Sep 2016 (UDI-DI 00833166007619), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K090807

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00833166007619 UDI-DI Date3 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090807 Date30 Jun 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090807 decided 30 Jun 2009 Active
  • FDA GUDID UDI-DI 00833166007619 listed 3 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0458-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009

    A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the potential to cause a burn if the POD is in direct contact with the patient.

Timeline

3 dated events

  1. Cleared FDA 510(k) K090807
  2. Recall initiated FDA recalls Z-0458-2010
  3. Listed FDA GUDID 00833166007619

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Nonin
Generic name
Electrical cable/lead holder
Model / reference
7600 TC-1
Primary DI / UDI-DI
00833166007619
510(k) Number
FDA product code
MUD
GMDN term
Electrical cable/lead holder
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Electrical cable/lead holder

Cleared under the same submission (K090807)

and 6 more cleared under K090807

Similar devices

Other devices filed under FDA product code MUD (Oximeter, Tissue Saturation).

Other devices from Nonin Medical, Inc.

See all devices from Nonin Medical, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)