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FDA 510(k)

MODEL 550-DC CROSSFIRE(TM)

K-Number: K945564 · 1995-06-01

ApplicantEclipse, Inc.
Decision Date1995-06-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 550-DC CROSSFIRE(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Eclipse, Inc.. It received FDA 510(k) clearance on 1995-06-01 under 510(k) number K945564. 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 MODEL 550-DC CROSSFIRE(TM)?

MODEL 550-DC CROSSFIRE(TM) is a medical device that received FDA 510(k) clearance on 1995-06-01. The listed applicant is Eclipse, Inc.. The 510(k) number is K945564.

When did MODEL 550-DC CROSSFIRE(TM) receive FDA 510(k) clearance?

MODEL 550-DC CROSSFIRE(TM) received FDA 510(k) clearance on 1995-06-01, under 510(k) number K945564.

Who is the listed applicant for MODEL 550-DC CROSSFIRE(TM)?

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

What is the FDA product code for MODEL 550-DC CROSSFIRE(TM)?

The FDA product code for MODEL 550-DC CROSSFIRE(TM) 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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