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FDA 510(k)

CORTEX DERMASCAN C ULTRASONIC SYSTEM

K-Number: K983945 · 1999-03-17

ApplicantCortex Technology Aps
Decision Date1999-03-17
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CORTEX DERMASCAN C ULTRASONIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cortex Technology Aps. It received FDA 510(k) clearance on 1999-03-17 under 510(k) number K983945. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORTEX DERMASCAN C ULTRASONIC SYSTEM?

CORTEX DERMASCAN C ULTRASONIC SYSTEM is a medical device that received FDA 510(k) clearance on 1999-03-17. The listed applicant is Cortex Technology Aps. The 510(k) number is K983945.

When did CORTEX DERMASCAN C ULTRASONIC SYSTEM receive FDA 510(k) clearance?

CORTEX DERMASCAN C ULTRASONIC SYSTEM received FDA 510(k) clearance on 1999-03-17, under 510(k) number K983945.

Who is the listed applicant for CORTEX DERMASCAN C ULTRASONIC SYSTEM?

The FDA 510(k) record lists Cortex Technology Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORTEX DERMASCAN C ULTRASONIC SYSTEM?

The FDA product code for CORTEX DERMASCAN C ULTRASONIC SYSTEM is IYO.

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 Cortex Technology Aps 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.

K982280CRYOPRO MAXI AND CRYOPRO MINI

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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