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Virtuox 1209

by Healthcare Logistics Systems

Virtuox 1209 is a Class II device made by Healthcare Logistics Systems, cleared under FDA 510(k) K100077 on 7 Oct 2010 and listed in FDA GUDID since 7 Dec 2016 (UDI-DI 00817698020124), 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) K100077

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 Number00817698020124 UDI-DI Date7 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100077 Date7 Oct 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100077 decided 7 Oct 2010 Active
  • FDA GUDID UDI-DI 00817698020124 listed 7 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100077
  2. Listed FDA GUDID 00817698020124

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Virtuox
Generic name
Pulse oximeter probe, reusable
Model / reference
1209
Primary DI / UDI-DI
00817698020124
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter probe, reusable
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulse oximeter probe, reusable

Cleared under the same submission (K100077)

and 8 more cleared under K100077

Other devices from Healthcare Logistics Systems

See all devices from Healthcare Logistics Systems →

Properties

  • Serial number
Other properties (14, all answered No)