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FDA 510(k)

WATCH-PAT 100

K-Number: K010739 · 2001-11-06

ApplicantItamar Medical (C.M.) 1997 , Ltd.
Decision Date2001-11-06
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WATCH-PAT 100 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 2001-11-06 under 510(k) number K010739. 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 100?

WATCH-PAT 100 is a medical device that received FDA 510(k) clearance on 2001-11-06. The listed applicant is Itamar Medical (C.M.) 1997 , Ltd.. The 510(k) number is K010739.

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

WATCH-PAT 100 received FDA 510(k) clearance on 2001-11-06, under 510(k) number K010739.

Who is the listed applicant for WATCH-PAT 100?

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 WATCH-PAT 100?

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

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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.

K010156SLEEP PAT 200 DEVICEK001852PERIPHERAL 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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