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FDA 510(k)

HUMANSCAN M5S-D ULTRASOUND TRANSDUCER

K-Number: K083824 · 2009-02-10

ApplicantHumanscan Company, Ltd.
Decision Date2009-02-10
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HUMANSCAN M5S-D ULTRASOUND TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Humanscan Company, Ltd.. It received FDA 510(k) clearance on 2009-02-10 under 510(k) number K083824. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMANSCAN M5S-D ULTRASOUND TRANSDUCER?

HUMANSCAN M5S-D ULTRASOUND TRANSDUCER is a medical device that received FDA 510(k) clearance on 2009-02-10. The listed applicant is Humanscan Company, Ltd.. The 510(k) number is K083824.

When did HUMANSCAN M5S-D ULTRASOUND TRANSDUCER receive FDA 510(k) clearance?

HUMANSCAN M5S-D ULTRASOUND TRANSDUCER received FDA 510(k) clearance on 2009-02-10, under 510(k) number K083824.

Who is the listed applicant for HUMANSCAN M5S-D ULTRASOUND TRANSDUCER?

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

What is the FDA product code for HUMANSCAN M5S-D ULTRASOUND TRANSDUCER?

The FDA product code for HUMANSCAN M5S-D ULTRASOUND TRANSDUCER is ITX.

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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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