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FDA 510(k)

Eclipse PRO

K-Number: K211651 · 2021-11-22

ApplicantSpacelabs Healthcare, Ltd.
Decision Date2021-11-22
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Eclipse PRO is a medical device manufactured by Spacelabs Healthcare, Ltd.. It received FDA 510(k) clearance on 2021-11-22 under approval number K211651. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eclipse PRO?

Eclipse PRO is a medical device that received FDA 510(k) clearance on 2021-11-22. It is manufactured by Spacelabs Healthcare, Ltd.. The 510(k) number is K211651.

When was Eclipse PRO approved by the FDA?

Eclipse PRO received FDA 510(k) clearance on 2021-11-22, under approval number K211651.

What company makes Eclipse PRO?

Eclipse PRO is manufactured by Spacelabs Healthcare, Ltd..

What is the FDA product code for Eclipse PRO?

The FDA product code for Eclipse PRO is MWJ.

Other Devices by Spacelabs Healthcare, Ltd.

K152881SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM K201921Spacelabs Lifescreen PRO Analyzer K212317Eclipse MINI Model 98900

Related Devices (Code: MWJ)

K161062NR RecorderNorav Medical GmbH K152626H3+ Holter RecorderMortara Instrument, Inc. K173156Integrated CardioRespiratory SystemSensydia, Inc. K212317Eclipse MINI Model 98900Spacelabs Healthcare, Ltd. K222017BiotresBiotricity K210758Q PatchMedicalgorithmics S.A.

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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