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Analyzer MaxO2+

by Maxtec, Inc. 3 variants

Analyzer MaxO2+ (R217P62-008) is a Class II device made by Maxtec, Inc., cleared under FDA 510(k) K040484 on 9 Jun 2004 and listed in FDA GUDID since 14 Aug 2024 (UDI-DI 00817770025948), 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) K040484

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 Number00817770025948 UDI-DI Date14 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK040484 Date9 Jun 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040484 decided 9 Jun 2004 Active
  • FDA GUDID UDI-DI 00817770025948 listed 14 Aug 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K040484
  2. Listed FDA GUDID 00817770025948

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Analyzer
Generic name
Respiratory oxygen monitor, line-powered
Model / Ref / Catalog
MaxO2+, R217P62-008
Primary DI / UDI-DI
00817770025948
510(k) Number
FDA product code
CCL
GMDN term
Respiratory oxygen monitor, line-powered
Device class
Class II
Regulation number
868.1720
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Respiratory oxygen monitor, line-powered

Cleared under the same submission (K040484)

and 8 more cleared under K040484

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

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)