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FDA 510(k)

WATCH-PAT MODEL 100S-2

K-Number: K080427 · 2008-05-23

ApplicantItamar Medical
Decision Date2008-05-23
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WATCH-PAT MODEL 100S-2 is the device name listed in this FDA 510(k) record. The listed applicant is Itamar Medical. It received FDA 510(k) clearance on 2008-05-23 under 510(k) number K080427. 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-PAT MODEL 100S-2?

WATCH-PAT MODEL 100S-2 is a medical device that received FDA 510(k) clearance on 2008-05-23. The listed applicant is Itamar Medical. The 510(k) number is K080427.

When did WATCH-PAT MODEL 100S-2 receive FDA 510(k) clearance?

WATCH-PAT MODEL 100S-2 received FDA 510(k) clearance on 2008-05-23, under 510(k) number K080427.

Who is the listed applicant for WATCH-PAT MODEL 100S-2?

The FDA 510(k) record lists Itamar Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WATCH-PAT MODEL 100S-2?

The FDA product code for WATCH-PAT MODEL 100S-2 is MNR.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Itamar Medical 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.

K081982WATCH-PAT 200S-2 (WP200S-2)K081037WATCH-PAT 200I (WP200I)K042916WATCH PAT 100SK032519ENDO PAT 2000

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.

K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbHK254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLCK253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressK252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

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.

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