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FDA 510(k)

Eclipse MINI Model 98900

K-Number: K212317 · 2022-11-07

ApplicantSpacelabs Healthcare, Ltd.
Decision Date2022-11-07
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Eclipse MINI Model 98900 is a medical device manufactured by Spacelabs Healthcare, Ltd.. It received FDA 510(k) clearance on 2022-11-07 under approval number K212317. 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 MINI Model 98900?

Eclipse MINI Model 98900 is a medical device that received FDA 510(k) clearance on 2022-11-07. It is manufactured by Spacelabs Healthcare, Ltd.. The 510(k) number is K212317.

When was Eclipse MINI Model 98900 approved by the FDA?

Eclipse MINI Model 98900 received FDA 510(k) clearance on 2022-11-07, under approval number K212317.

What company makes Eclipse MINI Model 98900?

Eclipse MINI Model 98900 is manufactured by Spacelabs Healthcare, Ltd..

What is the FDA product code for Eclipse MINI Model 98900?

The FDA product code for Eclipse MINI Model 98900 is MWJ.

Other Devices by Spacelabs Healthcare, Ltd.

K152881SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM K211651Eclipse PRO K201921Spacelabs Lifescreen PRO Analyzer

Related Devices (Code: MWJ)

K161062NR RecorderNorav Medical GmbH K152626H3+ Holter RecorderMortara Instrument, Inc. K173156Integrated CardioRespiratory SystemSensydia, Inc. K211651Eclipse PROSpacelabs 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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