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FDA 510(k)

CAPELLA

K-Number: K002200 · 2000-08-25

ApplicantMadsen Electronics, Inc.
Decision Date2000-08-25
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CAPELLA is the device name listed in this FDA 510(k) record. The listed applicant is Madsen Electronics, Inc.. It received FDA 510(k) clearance on 2000-08-25 under 510(k) number K002200. 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 CAPELLA?

CAPELLA is a medical device that received FDA 510(k) clearance on 2000-08-25. The listed applicant is Madsen Electronics, Inc.. The 510(k) number is K002200.

When did CAPELLA receive FDA 510(k) clearance?

CAPELLA received FDA 510(k) clearance on 2000-08-25, under 510(k) number K002200.

Who is the listed applicant for CAPELLA?

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

What is the FDA product code for CAPELLA?

The FDA product code for CAPELLA is EWO.

Related Clinical Trials

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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Other records listing Madsen Electronics, 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.

K983851CAPELLA COCHLEAR EMISSIONS ANALYZERK945199RH2000 REAL EAR MEASUREMENT SYSTEMK945032VOYAGER 522

Related Devices (Code: EWO)

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.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, Inc.

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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