WatchPAT ONE (WP1)— 510(k) K223675

Substantially Equivalent

Itamar Medical , Ltd.

FDA 510(k) clearance K223675 for WatchPAT ONE (WP1), Substantially Equivalent on 2023-01-06. Applicant: Itamar Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Itamar Medical , Ltd.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2022-12-07
Decision date: 2023-01-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNR

More clearances from Itamar Medical , Ltd.

K250460 — WatchPAT400 (WP400)2025-09-05
K211557 — EndoPATx2022-12-29
K222331 — WatchPAT300 (WP300)2022-09-14
K203839 — WatchPAT200U (WP200U)2022-03-21
K183559 — WatchPAT ONE2019-06-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.