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FDA 510(k)

EXA

K-Number: K203743 · 2021-12-10

ApplicantKonica Minolta Healthcare Americas, Inc.
Decision Date2021-12-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXA is the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta Healthcare Americas, Inc.. It received FDA 510(k) clearance on 2021-12-10 under 510(k) number K203743. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXA?

EXA is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Konica Minolta Healthcare Americas, Inc.. The 510(k) number is K203743.

When did EXA receive FDA 510(k) clearance?

EXA received FDA 510(k) clearance on 2021-12-10, under 510(k) number K203743.

Who is the listed applicant for EXA?

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

What is the FDA product code for EXA?

The FDA product code for EXA is LLZ.

Other records listing Konica Minolta Healthcare Americas, Inc. as applicant

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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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