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MaxVenturi International DISS

by Maxtec, Inc.

MaxVenturi International DISS (R211P03-124) is a Class II device made by Maxtec, Inc., cleared under FDA 510(k) K063488 on 22 Feb 2007 and listed in FDA GUDID since 8 Jun 2023 (UDI-DI 00817770025658), 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) K063488

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 Number00817770025658 UDI-DI Date8 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK063488 Date22 Feb 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K063488 decided 22 Feb 2007 Active
  • FDA GUDID UDI-DI 00817770025658 listed 8 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K063488
  2. Listed FDA GUDID 00817770025658

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MaxVenturi
Generic name
Respiratory oxygen monitor, battery-powered
Model / Ref / Catalog
International DISS, R211P03-124
Primary DI / UDI-DI
00817770025658
510(k) Number
FDA product code
CCL
GMDN term
Respiratory oxygen monitor, battery-powered
Device class
Class II
Regulation number
868.1720
GUDID distribution status
In Commercial Distribution

Related devices

Category: Respiratory oxygen monitor, battery-powered

Cleared under the same submission (K063488)

and 8 more cleared under K063488

Similar devices

Other devices filed under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase).

Other devices from Maxtec, Inc.

See all devices from Maxtec, Inc. →

Properties

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