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FDA 510(k)

AUTODERM SCANNER CONTROL CONSOLE

K-Number: K904266 · 1991-02-19

ApplicantCharles I. Rose & Co., Inc.
Decision Date1991-02-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AUTODERM SCANNER CONTROL CONSOLE is the device name listed in this FDA 510(k) record. The listed applicant is Charles I. Rose & Co., Inc.. It received FDA 510(k) clearance on 1991-02-19 under 510(k) number K904266. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTODERM SCANNER CONTROL CONSOLE?

AUTODERM SCANNER CONTROL CONSOLE is a medical device that received FDA 510(k) clearance on 1991-02-19. The listed applicant is Charles I. Rose & Co., Inc.. The 510(k) number is K904266.

When did AUTODERM SCANNER CONTROL CONSOLE receive FDA 510(k) clearance?

AUTODERM SCANNER CONTROL CONSOLE received FDA 510(k) clearance on 1991-02-19, under 510(k) number K904266.

Who is the listed applicant for AUTODERM SCANNER CONTROL CONSOLE?

The FDA 510(k) record lists Charles I. Rose & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTODERM SCANNER CONTROL CONSOLE?

The FDA product code for AUTODERM SCANNER CONTROL CONSOLE is GEX. This falls under the Gastroenterology category.

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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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