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FDA 510(k)

MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM

K-Number: K002544 · 2000-09-13

ApplicantOxford Instruments
Decision Date2000-09-13
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Instruments. It received FDA 510(k) clearance on 2000-09-13 under 510(k) number K002544. 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 MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM?

MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2000-09-13. The listed applicant is Oxford Instruments. The 510(k) number is K002544.

When did MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM receive FDA 510(k) clearance?

MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM received FDA 510(k) clearance on 2000-09-13, under 510(k) number K002544.

Who is the listed applicant for MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM?

The FDA 510(k) record lists Oxford Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM?

The FDA product code for MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM is DQK.

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Other records listing Oxford Instruments 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.

K002150SONICAID FM820, SONICAID FM830

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.

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

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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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