Watch-PAT300

510(k) Number

K180775 ↗

FDA product code

MNR

FDA applicant

Itamar Medical , Ltd.

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).

• Onera STS 01.00 by Onera B.V.
• SNAP TESTING DEVICE by Snap Laboratories, LLC
• Somté PSG 9023-0002-01 by COMPUMEDICS LIMITED
• SomnaPatch by Respironics, Inc.
• APNEA RISK EVALUATION SYSTEM (ARES) by Advanced Brain Monitoring, Inc.
• DROWZLE by Resonea, Inc.
• SILENT NIGHT I by Local Silence, Inc.
• AcuPebble OX100 by Acurable Limited
• Onera STS 01.00 ONERA STS1 HEAD by Onera B.V.
• MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM by Nellcor Puritan Bennett (Melville), Ltd.

• WatchPAT™ Central Plus Sensor

  Class IIa

  CE/MDR

• WatchPAT SW

  Class II

  FDA 510(k) K254042 Active Cleared 31 Jul 2026

• Endo PAT 2000

  Class II

  FDA 510(k) K032519 Active Cleared 12 Nov 2003 GUDID on market

• Anchors(30) for Endo PAT 2000

  Class II

  FDA 510(k) ×2 Active Cleared 12 Nov 2003 GUDID on market

See all devices from Itamar Medical Ltd →