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FDA 510(k)

CRAIGWELL AID FITTING SYSTEM AFS

K-Number: K854125 · 1986-01-16

ApplicantCraigwell Electronics, Ltd.
Decision Date1986-01-16
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CRAIGWELL AID FITTING SYSTEM AFS is the device name listed in this FDA 510(k) record. The listed applicant is Craigwell Electronics, Ltd.. It received FDA 510(k) clearance on 1986-01-16 under 510(k) number K854125. 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 CRAIGWELL AID FITTING SYSTEM AFS?

CRAIGWELL AID FITTING SYSTEM AFS is a medical device that received FDA 510(k) clearance on 1986-01-16. The listed applicant is Craigwell Electronics, Ltd.. The 510(k) number is K854125.

When did CRAIGWELL AID FITTING SYSTEM AFS receive FDA 510(k) clearance?

CRAIGWELL AID FITTING SYSTEM AFS received FDA 510(k) clearance on 1986-01-16, under 510(k) number K854125.

Who is the listed applicant for CRAIGWELL AID FITTING SYSTEM AFS?

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

What is the FDA product code for CRAIGWELL AID FITTING SYSTEM AFS?

The FDA product code for CRAIGWELL AID FITTING SYSTEM AFS 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 Craigwell Electronics, Ltd. 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.

K854124CRAIGWELL AID HA300K854126CRAIGWELL MASTER HEARING AID MHA

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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