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FDA 510(k)

KOOLINER II

K-Number: K935261 · 1994-01-26

ApplicantGC America, Inc.
Decision Date1994-01-26
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KOOLINER II is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 1994-01-26 under 510(k) number K935261. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOOLINER II?

KOOLINER II is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is GC America, Inc.. The 510(k) number is K935261.

When did KOOLINER II receive FDA 510(k) clearance?

KOOLINER II received FDA 510(k) clearance on 1994-01-26, under 510(k) number K935261.

Who is the listed applicant for KOOLINER II?

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

What is the FDA product code for KOOLINER II?

The FDA product code for KOOLINER II is EBI.

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Other records listing GC America, Inc. as applicant

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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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