Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Itamar Medical , Ltd.. It received FDA 510(k) clearance on 2018-08-17 under 510(k) 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. The listed applicant is Itamar Medical , Ltd.. The 510(k) number is K180775.

When did Watch-PAT300 receive FDA 510(k) clearance?

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

Who is the listed applicant for Watch-PAT300?

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-PAT300?

The FDA product code for Watch-PAT300 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.