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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 the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Healthcare, Ltd.. It received FDA 510(k) clearance on 2022-11-07 under 510(k) 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. The listed applicant is Spacelabs Healthcare, Ltd.. The 510(k) number is K212317.

When did Eclipse MINI Model 98900 receive FDA 510(k) clearance?

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

Who is the listed applicant for Eclipse MINI Model 98900?

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 MINI Model 98900?

The FDA product code for Eclipse MINI Model 98900 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.

K211651Eclipse PROK201921Spacelabs 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.K222017BiotresBiotricity

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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