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FDA 510(k)

PATHFINDER 700 HOLTER ANALYZER

K-Number: K951902 · 1996-07-15

ApplicantReynolds Medical , Ltd.
Decision Date1996-07-15
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PATHFINDER 700 HOLTER ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Reynolds Medical , Ltd.. It received FDA 510(k) clearance on 1996-07-15 under 510(k) number K951902. 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 PATHFINDER 700 HOLTER ANALYZER?

PATHFINDER 700 HOLTER ANALYZER is a medical device that received FDA 510(k) clearance on 1996-07-15. The listed applicant is Reynolds Medical , Ltd.. The 510(k) number is K951902.

When did PATHFINDER 700 HOLTER ANALYZER receive FDA 510(k) clearance?

PATHFINDER 700 HOLTER ANALYZER received FDA 510(k) clearance on 1996-07-15, under 510(k) number K951902.

Who is the listed applicant for PATHFINDER 700 HOLTER ANALYZER?

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

What is the FDA product code for PATHFINDER 700 HOLTER ANALYZER?

The FDA product code for PATHFINDER 700 HOLTER ANALYZER is DQK.

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Other records listing Reynolds Medical , Ltd. as applicant

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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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