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FDA 510(k)

PASCAL SYNTHESIS DELIVERY SYSTEM

K-Number: K081744 · 2008-09-09

ApplicantOptimedica Corporation
Decision Date2008-09-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PASCAL SYNTHESIS DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Optimedica Corporation. It received FDA 510(k) clearance on 2008-09-09 under 510(k) number K081744. 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 PASCAL SYNTHESIS DELIVERY SYSTEM?

PASCAL SYNTHESIS DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2008-09-09. The listed applicant is Optimedica Corporation. The 510(k) number is K081744.

When did PASCAL SYNTHESIS DELIVERY SYSTEM receive FDA 510(k) clearance?

PASCAL SYNTHESIS DELIVERY SYSTEM received FDA 510(k) clearance on 2008-09-09, under 510(k) number K081744.

Who is the listed applicant for PASCAL SYNTHESIS DELIVERY SYSTEM?

The FDA 510(k) record lists Optimedica Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PASCAL SYNTHESIS DELIVERY SYSTEM?

The FDA product code for PASCAL SYNTHESIS DELIVERY SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Optimedica Corporation as applicant

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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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