AcuPebble OX100

510(k) Number

K222950 ↗

FDA product code

MNR

Device class

Class II

Regulation

21 CFR Part 868.2375

Advisory committee

Anesthesiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code MNR (Ventilatory Effort Recorder).

• Compumedics Somte Somte PSG v2 8023-0001-02 by COMPUMEDICS LIMITED
• Watch-PAT 200S-2 (WP200S-2) by ITAMAR MEDICAL LTD
• Somnoscreen EEG10-20 by SOMNOmedics AG
• BRAEBON Communication Cable for MediByte 8889.21 by Braebon Medical Corp.
• Michele Sleep Scoring Systems by Younes Sleep Technologies
• Somnowatch by SOMNOmedics AG
• SnoreSounds Ventilatory Effort Recorder by Appian Medical, Inc.
• Watch-PAT 200S-3 (WP200S-3) by ITAMAR MEDICAL LTD
• Compumedics Summit IP by COMPUMEDICS USA, INC.
• Onera STS 01.00 by Onera B.V.

• Acurable Limited

  Class IIa

  CE/MDD

• AcuPebble Ox100

  Class II

  FDA 510(k) K222950 Active Cleared 3 Feb 2023 GUDID on market

• AcuPebble Ox (200)

  Class II

  FDA 510(k) K243092 Active Cleared 19 Mar 2025

• AcuPebble SA

  Class II

  FDA 510(k) K210480 Active Cleared 6 Jul 2021