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FDA 510(k)

PERFORMER 30 HPS

K-Number: K001322 · 2000-06-30

ApplicantCornelia Damsky, Inc.
Decision Date2000-06-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERFORMER 30 HPS is the device name listed in this FDA 510(k) record. The listed applicant is Cornelia Damsky, Inc.. It received FDA 510(k) clearance on 2000-06-30 under 510(k) number K001322. 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 PERFORMER 30 HPS?

PERFORMER 30 HPS is a medical device that received FDA 510(k) clearance on 2000-06-30. The listed applicant is Cornelia Damsky, Inc.. The 510(k) number is K001322.

When did PERFORMER 30 HPS receive FDA 510(k) clearance?

PERFORMER 30 HPS received FDA 510(k) clearance on 2000-06-30, under 510(k) number K001322.

Who is the listed applicant for PERFORMER 30 HPS?

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

What is the FDA product code for PERFORMER 30 HPS?

The FDA product code for PERFORMER 30 HPS 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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