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FDA 510(k)

CARDIOSEN'C

K-Number: K080047 · 2008-07-11

ApplicantShl Telemedicine International , Ltd.
Decision Date2008-07-11
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSEN'C is the device name listed in this FDA 510(k) record. The listed applicant is Shl Telemedicine International , Ltd.. It received FDA 510(k) clearance on 2008-07-11 under 510(k) number K080047. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOSEN'C?

CARDIOSEN'C is a medical device that received FDA 510(k) clearance on 2008-07-11. The listed applicant is Shl Telemedicine International , Ltd.. The 510(k) number is K080047.

When did CARDIOSEN'C receive FDA 510(k) clearance?

CARDIOSEN'C received FDA 510(k) clearance on 2008-07-11, under 510(k) number K080047.

Who is the listed applicant for CARDIOSEN'C?

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

What is the FDA product code for CARDIOSEN'C?

The FDA product code for CARDIOSEN'C is DXH. This falls under the Hematology category.

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Other records listing Shl Telemedicine International , 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.

K113514SMARTHEARTK063609RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTERK003392CARDIO MONITOR CENTER VISION; MODEL S-CV7-00K981807CARDIOVISION SOFTWARE, MODEL S-CV5-96

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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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