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FDA 510(k)

FDI 2000 ULTRASONIC SKIN SCANNER

K-Number: K902965 · 1990-09-26

ApplicantFulmer Dyson Intl.
Decision Date1990-09-26
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FDI 2000 ULTRASONIC SKIN SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Fulmer Dyson Intl.. It received FDA 510(k) clearance on 1990-09-26 under 510(k) number K902965. 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 FDI 2000 ULTRASONIC SKIN SCANNER?

FDI 2000 ULTRASONIC SKIN SCANNER is a medical device that received FDA 510(k) clearance on 1990-09-26. The listed applicant is Fulmer Dyson Intl.. The 510(k) number is K902965.

When did FDI 2000 ULTRASONIC SKIN SCANNER receive FDA 510(k) clearance?

FDI 2000 ULTRASONIC SKIN SCANNER received FDA 510(k) clearance on 1990-09-26, under 510(k) number K902965.

Who is the listed applicant for FDI 2000 ULTRASONIC SKIN SCANNER?

The FDA 510(k) record lists Fulmer Dyson Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FDI 2000 ULTRASONIC SKIN SCANNER?

The FDA product code for FDI 2000 ULTRASONIC SKIN SCANNER is IYO.

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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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