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FDA 510(k)

GC BASELINE

K-Number: K963144 · 1996-10-29

ApplicantGC America, Inc.
Decision Date1996-10-29
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC BASELINE 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 1996-10-29 under 510(k) number K963144. 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 GC BASELINE?

GC BASELINE is a medical device that received FDA 510(k) clearance on 1996-10-29. The listed applicant is GC America, Inc.. The 510(k) number is K963144.

When did GC BASELINE receive FDA 510(k) clearance?

GC BASELINE received FDA 510(k) clearance on 1996-10-29, under 510(k) number K963144.

Who is the listed applicant for GC BASELINE?

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 GC BASELINE?

The FDA product code for GC BASELINE is EBI.

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Other records listing GC America, Inc. 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.

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Related Devices (Code: EBI)

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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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