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FDA 510(k)

AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM

K-Number: K062048 · 2006-09-07

ApplicantAesthera Corporation
Decision Date2006-09-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesthera Corporation. It received FDA 510(k) clearance on 2006-09-07 under 510(k) number K062048. 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 AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM?

AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM is a medical device that received FDA 510(k) clearance on 2006-09-07. The listed applicant is Aesthera Corporation. The 510(k) number is K062048.

When did AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM receive FDA 510(k) clearance?

AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM received FDA 510(k) clearance on 2006-09-07, under 510(k) number K062048.

Who is the listed applicant for AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM?

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

What is the FDA product code for AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM?

The FDA product code for AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Aesthera Corporation 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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