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FDA 510(k)

SPACELABS PATHFINDER SL HOLTER ANALYZER

K-Number: K110001 · 2011-06-14

ApplicantSpacelabs Healthcare, Ltd.
Decision Date2011-06-14
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPACELABS PATHFINDER SL HOLTER 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 2011-06-14 under 510(k) number K110001. 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 PATHFINDER SL HOLTER ANALYZER?

SPACELABS PATHFINDER SL HOLTER ANALYZER is a medical device that received FDA 510(k) clearance on 2011-06-14. The listed applicant is Spacelabs Healthcare, Ltd.. The 510(k) number is K110001.

When did SPACELABS PATHFINDER SL HOLTER ANALYZER receive FDA 510(k) clearance?

SPACELABS PATHFINDER SL HOLTER ANALYZER received FDA 510(k) clearance on 2011-06-14, under 510(k) number K110001.

Who is the listed applicant for SPACELABS PATHFINDER SL HOLTER 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 PATHFINDER SL HOLTER ANALYZER?

The FDA product code for SPACELABS PATHFINDER SL HOLTER ANALYZER is DQK.

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Other records listing Spacelabs Healthcare, Ltd. as applicant

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K212317Eclipse MINI Model 98900K211651Eclipse PROK201921Spacelabs Lifescreen PRO AnalyzerK152881SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEMK130207SPACELABS HEALTHCARE CARDIOEXPRESSK101850SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION

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Related Devices (Code: DQK)

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K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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