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FDA 510(k)

ECLIPSE 2100

K-Number: K955006 · 1996-01-17

ApplicantCardiogenes
Decision Date1996-01-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ECLIPSE 2100 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiogenes. It received FDA 510(k) clearance on 1996-01-17 under 510(k) number K955006. 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 ECLIPSE 2100?

ECLIPSE 2100 is a medical device that received FDA 510(k) clearance on 1996-01-17. The listed applicant is Cardiogenes. The 510(k) number is K955006.

When did ECLIPSE 2100 receive FDA 510(k) clearance?

ECLIPSE 2100 received FDA 510(k) clearance on 1996-01-17, under 510(k) number K955006.

Who is the listed applicant for ECLIPSE 2100?

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

What is the FDA product code for ECLIPSE 2100?

The FDA product code for ECLIPSE 2100 is GEX. This falls under the Gastroenterology category.

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Other records listing Cardiogenes as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961560ECLIPSE 2000K952755POWERSCULPTOR PROBESK953658CORSSFIRE PLUSK953424ECLIPSE 3200K945126ECLIPSE 3200K944758SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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