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FDA 510(k)

DLASE 300 UPGRADE

K-Number: K932065 · 1993-07-22

ApplicantIncirt Tech., Inc.
Decision Date1993-07-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DLASE 300 UPGRADE is the device name listed in this FDA 510(k) record. The listed applicant is Incirt Tech., Inc.. It received FDA 510(k) clearance on 1993-07-22 under 510(k) number K932065. 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 DLASE 300 UPGRADE?

DLASE 300 UPGRADE is a medical device that received FDA 510(k) clearance on 1993-07-22. The listed applicant is Incirt Tech., Inc.. The 510(k) number is K932065.

When did DLASE 300 UPGRADE receive FDA 510(k) clearance?

DLASE 300 UPGRADE received FDA 510(k) clearance on 1993-07-22, under 510(k) number K932065.

Who is the listed applicant for DLASE 300 UPGRADE?

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

What is the FDA product code for DLASE 300 UPGRADE?

The FDA product code for DLASE 300 UPGRADE 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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