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FDA 510(k)

WatchPAT SW

K-Number: K254042 · 2026-07-31

Decision Date2026-07-31
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WatchPAT SW 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 2026-07-31 under 510(k) number K254042. 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 SW?

WatchPAT SW is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is Itamar Medical , Ltd.. The 510(k) number is K254042.

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

WatchPAT SW received FDA 510(k) clearance on 2026-07-31, under 510(k) number K254042.

Who is the listed applicant for WatchPAT SW?

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 SW?

The FDA product code for WatchPAT SW 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.

View all 10 devices →

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

View on FDA Database →

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