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FDA 510(k)

DENLASER 800 PLUS

K-Number: K061366 · 2006-07-10

ApplicantCAO Group, Inc.
Decision Date2006-07-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DENLASER 800 PLUS is the device name listed in this FDA 510(k) record. The listed applicant is CAO Group, Inc.. It received FDA 510(k) clearance on 2006-07-10 under 510(k) number K061366. 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 DENLASER 800 PLUS?

DENLASER 800 PLUS is a medical device that received FDA 510(k) clearance on 2006-07-10. The listed applicant is CAO Group, Inc.. The 510(k) number is K061366.

When did DENLASER 800 PLUS receive FDA 510(k) clearance?

DENLASER 800 PLUS received FDA 510(k) clearance on 2006-07-10, under 510(k) number K061366.

Who is the listed applicant for DENLASER 800 PLUS?

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

What is the FDA product code for DENLASER 800 PLUS?

The FDA product code for DENLASER 800 PLUS 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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