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FDA 510(k)

CARDIOCT

K-Number: K070226 · 2007-03-09

ApplicantShina Systems , Ltd.
Decision Date2007-03-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIOCT is the device name listed in this FDA 510(k) record. The listed applicant is Shina Systems , Ltd.. It received FDA 510(k) clearance on 2007-03-09 under 510(k) number K070226. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOCT?

CARDIOCT is a medical device that received FDA 510(k) clearance on 2007-03-09. The listed applicant is Shina Systems , Ltd.. The 510(k) number is K070226.

When did CARDIOCT receive FDA 510(k) clearance?

CARDIOCT received FDA 510(k) clearance on 2007-03-09, under 510(k) number K070226.

Who is the listed applicant for CARDIOCT?

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

What is the FDA product code for CARDIOCT?

The FDA product code for CARDIOCT is LLZ.

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Other records listing Shina Systems , Ltd. 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.

K1134423DIK1125303DI INCLUDING CSCOREK0937033DI

Related Devices (Code: LLZ)

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.

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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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