WatchPAT ONE— 510(k) K183559

Substantially Equivalent

Itamar Medical , Ltd.

FDA 510(k) clearance K183559 for WatchPAT ONE, Substantially Equivalent on 2019-06-05. 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: 2018-12-20
Decision date: 2019-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNR

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K211557 — EndoPATx2022-12-29
K222331 — WatchPAT300 (WP300)2022-09-14
K203839 — WatchPAT200U (WP200U)2022-03-21

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