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FDA 510(k)

CHROMOSCAN SCANNING SYSTEM

K-Number: K980753 · 1998-06-29

ApplicantMehl/Biophile Intl., Inc.
Decision Date1998-06-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CHROMOSCAN SCANNING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mehl/Biophile Intl., Inc.. It received FDA 510(k) clearance on 1998-06-29 under 510(k) number K980753. 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 CHROMOSCAN SCANNING SYSTEM?

CHROMOSCAN SCANNING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-06-29. The listed applicant is Mehl/Biophile Intl., Inc.. The 510(k) number is K980753.

When did CHROMOSCAN SCANNING SYSTEM receive FDA 510(k) clearance?

CHROMOSCAN SCANNING SYSTEM received FDA 510(k) clearance on 1998-06-29, under 510(k) number K980753.

Who is the listed applicant for CHROMOSCAN SCANNING SYSTEM?

The FDA 510(k) record lists Mehl/Biophile Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHROMOSCAN SCANNING SYSTEM?

The FDA product code for CHROMOSCAN SCANNING SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Mehl/Biophile Intl., Inc. 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.

K971814IMPROVEMENTS TO THE MEHL RUBY LASER

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Official Source

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