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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 the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Healthcare, Ltd.. It received FDA 510(k) clearance on 2021-11-22 under 510(k) 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. The listed applicant is Spacelabs Healthcare, Ltd.. The 510(k) number is K211651.

When did Eclipse PRO receive FDA 510(k) clearance?

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

Who is the listed applicant for Eclipse PRO?

The FDA 510(k) record lists Spacelabs Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Eclipse PRO?

The FDA product code for Eclipse PRO is MWJ.

Other records listing Spacelabs Healthcare, 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.

K212317Eclipse MINI Model 98900K201921Spacelabs Lifescreen PRO AnalyzerK152881SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

Related Devices (Code: MWJ)

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.

K253562medilogFDSchiller AGK253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)Seers Technology Co., Ltd.K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.K231424HeartBeam AIMIGo(TM) SystemHeartbeam, Inc.K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.K212317Eclipse MINI Model 98900Spacelabs Healthcare, Ltd.

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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