WATCH-PAT 200S-3 (WP200S-3)— 510(k) K102567

Name: FDA 510(k) clearance K102567
Creator: U.S. Food and Drug Administration
Published: 2011-06-02

Substantially Equivalent

Itamar Medical , Ltd.

FDA 510(k) clearance K102567 for WATCH-PAT 200S-3 (WP200S-3), Substantially Equivalent on 2011-06-02. 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: 2010-09-07
Decision date: 2011-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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