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FDA 510(k)

OMEGA CARES SYSTEM

K-Number: K945068 · 1996-01-25

ApplicantJ-F Medical Systems Intl., Inc.
Decision Date1996-01-25
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMEGA CARES SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is J-F Medical Systems Intl., Inc.. It received FDA 510(k) clearance on 1996-01-25 under 510(k) number K945068. 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 OMEGA CARES SYSTEM?

OMEGA CARES SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-25. The listed applicant is J-F Medical Systems Intl., Inc.. The 510(k) number is K945068.

When did OMEGA CARES SYSTEM receive FDA 510(k) clearance?

OMEGA CARES SYSTEM received FDA 510(k) clearance on 1996-01-25, under 510(k) number K945068.

Who is the listed applicant for OMEGA CARES SYSTEM?

The FDA 510(k) record lists J-F Medical Systems Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMEGA CARES SYSTEM?

The FDA product code for OMEGA CARES SYSTEM 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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