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FDA 510(k)

Spacelabs Lifescreen PRO Analyzer

K-Number: K201921 · 2021-03-26

ApplicantSpacelabs Healthcare, Ltd.
Decision Date2021-03-26
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Spacelabs Lifescreen PRO Analyzer 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 2021-03-26 under 510(k) number K201921. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spacelabs Lifescreen PRO Analyzer?

Spacelabs Lifescreen PRO Analyzer is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Spacelabs Healthcare, Ltd.. The 510(k) number is K201921.

When did Spacelabs Lifescreen PRO Analyzer receive FDA 510(k) clearance?

Spacelabs Lifescreen PRO Analyzer received FDA 510(k) clearance on 2021-03-26, under 510(k) number K201921.

Who is the listed applicant for Spacelabs Lifescreen PRO Analyzer?

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 Spacelabs Lifescreen PRO Analyzer?

The FDA product code for Spacelabs Lifescreen PRO Analyzer is DQK.

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.

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Related Devices (Code: DQK)

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.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, 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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