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FDA 510(k)

POST-AURICULAR HEARING AID (#PE830)

K-Number: K810030 · 1981-01-14

ApplicantHc Electronics
Decision Date1981-01-14
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

POST-AURICULAR HEARING AID (#PE830) is the device name listed in this FDA 510(k) record. The listed applicant is Hc Electronics. It received FDA 510(k) clearance on 1981-01-14 under 510(k) number K810030. 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 POST-AURICULAR HEARING AID (#PE830)?

POST-AURICULAR HEARING AID (#PE830) is a medical device that received FDA 510(k) clearance on 1981-01-14. The listed applicant is Hc Electronics. The 510(k) number is K810030.

When did POST-AURICULAR HEARING AID (#PE830) receive FDA 510(k) clearance?

POST-AURICULAR HEARING AID (#PE830) received FDA 510(k) clearance on 1981-01-14, under 510(k) number K810030.

Who is the listed applicant for POST-AURICULAR HEARING AID (#PE830)?

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 POST-AURICULAR HEARING AID (#PE830)?

The FDA product code for POST-AURICULAR HEARING AID (#PE830) 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 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)K800340PHONIC EAR, MODEL 841LK782053HEARING AID, POST-AURICULARK780936PHONIC EARK780363PHONIC EARK772347PHONIC MIRROR HANDIVOICE MODEL 120

View all 10 devices →

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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