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FDA 510(k)

PHONIC EAR, MODEL 841L

K-Number: K800340 · 1980-02-26

ApplicantHc Electronics
Decision Date1980-02-26
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PHONIC EAR, MODEL 841L is the device name listed in this FDA 510(k) record. The listed applicant is Hc Electronics. It received FDA 510(k) clearance on 1980-02-26 under 510(k) number K800340. 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 PHONIC EAR, MODEL 841L?

PHONIC EAR, MODEL 841L is a medical device that received FDA 510(k) clearance on 1980-02-26. The listed applicant is Hc Electronics. The 510(k) number is K800340.

When did PHONIC EAR, MODEL 841L receive FDA 510(k) clearance?

PHONIC EAR, MODEL 841L received FDA 510(k) clearance on 1980-02-26, under 510(k) number K800340.

Who is the listed applicant for PHONIC EAR, MODEL 841L?

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

What is the FDA product code for PHONIC EAR, MODEL 841L?

The FDA product code for PHONIC EAR, MODEL 841L is ESD.

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Other records listing Hc Electronics 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.

K810031STEREO AUDITORY TRAINER (MODEL PM228)K810030POST-AURICULAR HEARING AID (#PE830)K782053HEARING AID, POST-AURICULARK780936PHONIC EARK780363PHONIC EARK772347PHONIC MIRROR HANDIVOICE MODEL 120

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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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