Watch-PAT200U
K-Number: K153070 · 2016-07-26
ApplicantItamar Medical , Ltd.
Decision Date2016-07-26
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Watch-PAT200U is a medical device manufactured by Itamar Medical , Ltd.. It received FDA 510(k) clearance on 2016-07-26 under approval number K153070. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Watch-PAT200U?
Watch-PAT200U is a medical device that received FDA 510(k) clearance on 2016-07-26. It is manufactured by Itamar Medical , Ltd.. The 510(k) number is K153070.
When was Watch-PAT200U approved by the FDA?
Watch-PAT200U received FDA 510(k) clearance on 2016-07-26, under approval number K153070.
What company makes Watch-PAT200U?
Watch-PAT200U is manufactured by Itamar Medical , Ltd..
What is the FDA product code for Watch-PAT200U?
The FDA product code for Watch-PAT200U is MNR.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.