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FDA 510(k)

WATCH PAT 100S

K-Number: K042916 · 2004-12-29

ApplicantItamar Medical
Decision Date2004-12-29
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WATCH PAT 100S is the device name listed in this FDA 510(k) record. The listed applicant is Itamar Medical. It received FDA 510(k) clearance on 2004-12-29 under 510(k) number K042916. 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 100S?

WATCH PAT 100S is a medical device that received FDA 510(k) clearance on 2004-12-29. The listed applicant is Itamar Medical. The 510(k) number is K042916.

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

WATCH PAT 100S received FDA 510(k) clearance on 2004-12-29, under 510(k) number K042916.

Who is the listed applicant for WATCH PAT 100S?

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 100S?

The FDA product code for WATCH PAT 100S 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)K080427WATCH-PAT MODEL 100S-2K032519ENDO 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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