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FDA 510(k)

BIOSYAG MEDICAL SYSTEM

K-Number: K080374 · 2008-05-15

ApplicantBios S.R.L.
Decision Date2008-05-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOSYAG MEDICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bios S.R.L.. It received FDA 510(k) clearance on 2008-05-15 under 510(k) number K080374. 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 BIOSYAG MEDICAL SYSTEM?

BIOSYAG MEDICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-15. The listed applicant is Bios S.R.L.. The 510(k) number is K080374.

When did BIOSYAG MEDICAL SYSTEM receive FDA 510(k) clearance?

BIOSYAG MEDICAL SYSTEM received FDA 510(k) clearance on 2008-05-15, under 510(k) number K080374.

Who is the listed applicant for BIOSYAG MEDICAL SYSTEM?

The FDA 510(k) record lists Bios S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSYAG MEDICAL SYSTEM?

The FDA product code for BIOSYAG MEDICAL SYSTEM 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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