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FDA 510(k)

WatchPAT200U (WP200U)

K-Number: K203839 · 2022-03-21

Decision Date2022-03-21
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WatchPAT200U (WP200U) 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 2022-03-21 under 510(k) number K203839. 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 WatchPAT200U (WP200U)?

WatchPAT200U (WP200U) is a medical device that received FDA 510(k) clearance on 2022-03-21. The listed applicant is Itamar Medical , Ltd.. The 510(k) number is K203839.

When did WatchPAT200U (WP200U) receive FDA 510(k) clearance?

WatchPAT200U (WP200U) received FDA 510(k) clearance on 2022-03-21, under 510(k) number K203839.

Who is the listed applicant for WatchPAT200U (WP200U)?

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 WatchPAT200U (WP200U)?

The FDA product code for WatchPAT200U (WP200U) 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.