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FDA 510(k)

HOLTER 6000

K-Number: K950988 · 1996-01-04

ApplicantOmega Medical Services, Inc.
Decision Date1996-01-04
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTER 6000 is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Services, Inc.. It received FDA 510(k) clearance on 1996-01-04 under 510(k) number K950988. 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 HOLTER 6000?

HOLTER 6000 is a medical device that received FDA 510(k) clearance on 1996-01-04. The listed applicant is Omega Medical Services, Inc.. The 510(k) number is K950988.

When did HOLTER 6000 receive FDA 510(k) clearance?

HOLTER 6000 received FDA 510(k) clearance on 1996-01-04, under 510(k) number K950988.

Who is the listed applicant for HOLTER 6000?

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

What is the FDA product code for HOLTER 6000?

The FDA product code for HOLTER 6000 is DQK.

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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.

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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