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FDA 510(k)

Watch-PAT200U

K-Number: K153070 · 2016-07-26

Decision Date2016-07-26
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Watch-PAT200U 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 2016-07-26 under 510(k) 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. The listed applicant is Itamar Medical , Ltd.. The 510(k) number is K153070.

When did Watch-PAT200U receive FDA 510(k) clearance?

Watch-PAT200U received FDA 510(k) clearance on 2016-07-26, under 510(k) number K153070.

Who is the listed applicant for Watch-PAT200U?

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 Watch-PAT200U?

The FDA product code for Watch-PAT200U 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.