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FDA 510(k)

SLEEP PAT 200 DEVICE

K-Number: K010156 · 2002-06-19

ApplicantItamar Medical (C.M.) 1997 , Ltd.
Decision Date2002-06-19
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEP PAT 200 DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Itamar Medical (C.M.) 1997 , Ltd.. It received FDA 510(k) clearance on 2002-06-19 under 510(k) number K010156. 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 SLEEP PAT 200 DEVICE?

SLEEP PAT 200 DEVICE is a medical device that received FDA 510(k) clearance on 2002-06-19. The listed applicant is Itamar Medical (C.M.) 1997 , Ltd.. The 510(k) number is K010156.

When did SLEEP PAT 200 DEVICE receive FDA 510(k) clearance?

SLEEP PAT 200 DEVICE received FDA 510(k) clearance on 2002-06-19, under 510(k) number K010156.

Who is the listed applicant for SLEEP PAT 200 DEVICE?

The FDA 510(k) record lists Itamar Medical (C.M.) 1997 , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLEEP PAT 200 DEVICE?

The FDA product code for SLEEP PAT 200 DEVICE is MNR.

Related Clinical Trials

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Other records listing Itamar Medical (C.M.) 1997 , 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.

K010739WATCH-PAT 100K001852PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE

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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