WATCH-PAT200U (WP200U)— 510(k) K133859

Substantially Equivalent

Itamar Medical , Ltd.

FDA 510(k) clearance K133859 for WATCH-PAT200U (WP200U), Substantially Equivalent on 2014-05-30. 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: 2013-12-19
Decision date: 2014-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNR

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