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FDA 510(k)

CRAIGWELL AID HA300

K-Number: K854124 · 1986-03-26

ApplicantCraigwell Electronics, Ltd.
Decision Date1986-03-26
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CRAIGWELL AID HA300 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 1986-03-26 under 510(k) number K854124. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRAIGWELL AID HA300?

CRAIGWELL AID HA300 is a medical device that received FDA 510(k) clearance on 1986-03-26. The listed applicant is Craigwell Electronics, Ltd.. The 510(k) number is K854124.

When did CRAIGWELL AID HA300 receive FDA 510(k) clearance?

CRAIGWELL AID HA300 received FDA 510(k) clearance on 1986-03-26, under 510(k) number K854124.

Who is the listed applicant for CRAIGWELL AID HA300?

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 HA300?

The FDA product code for CRAIGWELL AID HA300 is ESD.

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.

K854126CRAIGWELL MASTER HEARING AID MHAK854125CRAIGWELL AID FITTING SYSTEM AFS

Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, 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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