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FDA 510(k)

ECLIPSE 2100(TM) MODEL 32, MODIFICATION

K-Number: K931101 · 1993-08-25

ApplicantCardiogenes
Decision Date1993-08-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ECLIPSE 2100(TM) MODEL 32, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Cardiogenes. It received FDA 510(k) clearance on 1993-08-25 under 510(k) number K931101. 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(TM) MODEL 32, MODIFICATION?

ECLIPSE 2100(TM) MODEL 32, MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-08-25. The listed applicant is Cardiogenes. The 510(k) number is K931101.

When did ECLIPSE 2100(TM) MODEL 32, MODIFICATION receive FDA 510(k) clearance?

ECLIPSE 2100(TM) MODEL 32, MODIFICATION received FDA 510(k) clearance on 1993-08-25, under 510(k) number K931101.

Who is the listed applicant for ECLIPSE 2100(TM) MODEL 32, MODIFICATION?

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(TM) MODEL 32, MODIFICATION?

The FDA product code for ECLIPSE 2100(TM) MODEL 32, MODIFICATION 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 2000K955006ECLIPSE 2100K952755POWERSCULPTOR PROBESK953658CORSSFIRE PLUSK953424ECLIPSE 3200K945126ECLIPSE 3200

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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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