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FDA 510(k)

FOX MEDICAL DIODE LASER SYSTEM 810NM

K-Number: K063104 · 2007-05-16

ApplicantHoward Instruments, Inc.
Decision Date2007-05-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FOX MEDICAL DIODE LASER SYSTEM 810NM is the device name listed in this FDA 510(k) record. The listed applicant is Howard Instruments, Inc.. It received FDA 510(k) clearance on 2007-05-16 under 510(k) number K063104. 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 FOX MEDICAL DIODE LASER SYSTEM 810NM?

FOX MEDICAL DIODE LASER SYSTEM 810NM is a medical device that received FDA 510(k) clearance on 2007-05-16. The listed applicant is Howard Instruments, Inc.. The 510(k) number is K063104.

When did FOX MEDICAL DIODE LASER SYSTEM 810NM receive FDA 510(k) clearance?

FOX MEDICAL DIODE LASER SYSTEM 810NM received FDA 510(k) clearance on 2007-05-16, under 510(k) number K063104.

Who is the listed applicant for FOX MEDICAL DIODE LASER SYSTEM 810NM?

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

What is the FDA product code for FOX MEDICAL DIODE LASER SYSTEM 810NM?

The FDA product code for FOX MEDICAL DIODE LASER SYSTEM 810NM is GEX. This falls under the Gastroenterology category.

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Other records listing Howard Instruments, Inc. as applicant

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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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