FDA 510(k)

CCA-200

K-Number: K981439 · 1998-06-15

Decision Date1998-06-15

Product CodeEWO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

CCA-200 is the device name listed in this FDA 510(k) record. The listed applicant is Benson Medical Instruments Co.. It received FDA 510(k) clearance on 1998-06-15 under 510(k) number K981439. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CCA-200?

CCA-200 is a medical device that received FDA 510(k) clearance on 1998-06-15. The listed applicant is Benson Medical Instruments Co.. The 510(k) number is K981439.

When did CCA-200 receive FDA 510(k) clearance?

CCA-200 received FDA 510(k) clearance on 1998-06-15, under 510(k) number K981439.

Who is the listed applicant for CCA-200?

The FDA 510(k) record lists Benson Medical Instruments Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CCA-200?

The FDA product code for CCA-200 is EWO.

Other records listing Benson Medical Instruments Co. 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.

K123896CCS-200 SPIROMETER K982441CCA-220 K963681CCA-100 (MODIFIED)K924652BENSON CCA100

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K234095OtoNova/OtoNova ProOtodynamics K240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH K191372LyraInteracoustics A/S K180287GSI CortiGrason-Stadler, Inc.

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.