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Invos 5100C-Jp

by Covidien LP

Invos 5100C-Jp is a Class II device made by Covidien LP, cleared under FDA 510(k) K091224 on 9 Jul 2009 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884521211186), active as of 23 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 23 Oct 2026

Documents

510(k) K091224

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 Number10884521211186 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK091224 Date9 Jul 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091224 decided 9 Jul 2009 Active
  • FDA GUDID UDI-DI 10884521211186 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091224
  2. Listed FDA GUDID 10884521211186

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Invos
Generic name
Cerebral oximeter
Model / reference
5100C-JP
Primary DI / UDI-DI
10884521211186
510(k) Number
FDA product code
MUD
GMDN term
Cerebral oximeter
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

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Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)