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FDA 510(k)

Watch-PAT300

K-Number: K180775 · 2018-08-17

Decision Date2018-08-17
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Watch-PAT300 is a medical device manufactured by Itamar Medical , Ltd.. It received FDA 510(k) clearance on 2018-08-17 under approval number K180775. 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-PAT300?

Watch-PAT300 is a medical device that received FDA 510(k) clearance on 2018-08-17. It is manufactured by Itamar Medical , Ltd.. The 510(k) number is K180775.

When was Watch-PAT300 approved by the FDA?

Watch-PAT300 received FDA 510(k) clearance on 2018-08-17, under approval number K180775.

What company makes Watch-PAT300?

Watch-PAT300 is manufactured by Itamar Medical , Ltd..

What is the FDA product code for Watch-PAT300?

The FDA product code for Watch-PAT300 is MNR.

Other Devices by Itamar Medical , Ltd.

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Related Devices (Code: MNR)

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.