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FDA 510(k)

EXCELL 22

K-Number: K991539 · 1999-07-01

ApplicantMwi, Inc.
Decision Date1999-07-01
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EXCELL 22 is the device name listed in this FDA 510(k) record. The listed applicant is Mwi, Inc.. It received FDA 510(k) clearance on 1999-07-01 under 510(k) number K991539. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCELL 22?

EXCELL 22 is a medical device that received FDA 510(k) clearance on 1999-07-01. The listed applicant is Mwi, Inc.. The 510(k) number is K991539.

When did EXCELL 22 receive FDA 510(k) clearance?

EXCELL 22 received FDA 510(k) clearance on 1999-07-01, under 510(k) number K991539.

Who is the listed applicant for EXCELL 22?

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

What is the FDA product code for EXCELL 22?

The FDA product code for EXCELL 22 is GKZ.

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Related Devices (Code: GKZ)

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

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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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