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FDA 510(k)

EZSENSOR P DIGITAL INTRAORAL SENSOR

K-Number: K121132 · 2012-05-10

ApplicantHumanray Co,Ltd
Decision Date2012-05-10
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EZSENSOR P DIGITAL INTRAORAL SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Humanray Co,Ltd. It received FDA 510(k) clearance on 2012-05-10 under 510(k) number K121132. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZSENSOR P DIGITAL INTRAORAL SENSOR?

EZSENSOR P DIGITAL INTRAORAL SENSOR is a medical device that received FDA 510(k) clearance on 2012-05-10. The listed applicant is Humanray Co,Ltd. The 510(k) number is K121132.

When did EZSENSOR P DIGITAL INTRAORAL SENSOR receive FDA 510(k) clearance?

EZSENSOR P DIGITAL INTRAORAL SENSOR received FDA 510(k) clearance on 2012-05-10, under 510(k) number K121132.

Who is the listed applicant for EZSENSOR P DIGITAL INTRAORAL SENSOR?

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

What is the FDA product code for EZSENSOR P DIGITAL INTRAORAL SENSOR?

The FDA product code for EZSENSOR P DIGITAL INTRAORAL SENSOR is MQB.

Related Clinical Trials

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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Other records listing Humanray Co,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.

K113360MEDICAL IMAGE PROCESSING UNIT

Related Devices (Code: MQB)

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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