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FDA 510(k)

SOUNDSKIN PHOTOTHERAPY SYSTEM

K-Number: K040103 · 2005-01-18

ApplicantBhc International, Ltd.
Decision Date2005-01-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOUNDSKIN PHOTOTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bhc International, Ltd.. It received FDA 510(k) clearance on 2005-01-18 under 510(k) number K040103. 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 SOUNDSKIN PHOTOTHERAPY SYSTEM?

SOUNDSKIN PHOTOTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2005-01-18. The listed applicant is Bhc International, Ltd.. The 510(k) number is K040103.

When did SOUNDSKIN PHOTOTHERAPY SYSTEM receive FDA 510(k) clearance?

SOUNDSKIN PHOTOTHERAPY SYSTEM received FDA 510(k) clearance on 2005-01-18, under 510(k) number K040103.

Who is the listed applicant for SOUNDSKIN PHOTOTHERAPY SYSTEM?

The FDA 510(k) record lists Bhc International, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOUNDSKIN PHOTOTHERAPY SYSTEM?

The FDA product code for SOUNDSKIN PHOTOTHERAPY SYSTEM 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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