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FDA 510(k)

UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED

K-Number: K943045 · 1994-12-13

ApplicantReliant Technologies, Inc.
Decision Date1994-12-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED is the device name listed in this FDA 510(k) record. The listed applicant is Reliant Technologies, Inc.. It received FDA 510(k) clearance on 1994-12-13 under 510(k) number K943045. 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 UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED?

UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED is a medical device that received FDA 510(k) clearance on 1994-12-13. The listed applicant is Reliant Technologies, Inc.. The 510(k) number is K943045.

When did UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED receive FDA 510(k) clearance?

UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED received FDA 510(k) clearance on 1994-12-13, under 510(k) number K943045.

Who is the listed applicant for UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED?

The FDA 510(k) record lists Reliant Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED?

The FDA product code for UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED is GEX. This falls under the Gastroenterology category.

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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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