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FDA 510(k)

WatchPAT ONE

K-Number: K183559 · 2019-06-05

Decision Date2019-06-05
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WatchPAT ONE is the device name listed in this FDA 510(k) record. The listed applicant is Itamar Medical , Ltd.. It received FDA 510(k) clearance on 2019-06-05 under 510(k) number K183559. 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 WatchPAT ONE?

WatchPAT ONE is a medical device that received FDA 510(k) clearance on 2019-06-05. The listed applicant is Itamar Medical , Ltd.. The 510(k) number is K183559.

When did WatchPAT ONE receive FDA 510(k) clearance?

WatchPAT ONE received FDA 510(k) clearance on 2019-06-05, under 510(k) number K183559.

Who is the listed applicant for WatchPAT ONE?

The FDA 510(k) record lists Itamar Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WatchPAT ONE?

The FDA product code for WatchPAT ONE is MNR.

Other records listing Itamar Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.