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FDA 510(k)

PHONIC EAR MODEL PE805CD

K-Number: K813583 · 1982-01-12

ApplicantPhonic Ear, Inc.
Decision Date1982-01-12
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PHONIC EAR MODEL PE805CD is the device name listed in this FDA 510(k) record. The listed applicant is Phonic Ear, Inc.. It received FDA 510(k) clearance on 1982-01-12 under 510(k) number K813583. 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 PE805CD?

PHONIC EAR MODEL PE805CD is a medical device that received FDA 510(k) clearance on 1982-01-12. The listed applicant is Phonic Ear, Inc.. The 510(k) number is K813583.

When did PHONIC EAR MODEL PE805CD receive FDA 510(k) clearance?

PHONIC EAR MODEL PE805CD received FDA 510(k) clearance on 1982-01-12, under 510(k) number K813583.

Who is the listed applicant for PHONIC EAR MODEL PE805CD?

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

What is the FDA product code for PHONIC EAR MODEL PE805CD?

The FDA product code for PHONIC EAR MODEL PE805CD is ESD.

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Other records listing Phonic Ear, 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.

K043090EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMSK974658INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, ITK974287FM RECEIVER - AUDITORY TRAINERK950730GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)K940313PHONIC EARK923234PE 400IR, PE 400T, PE 400E

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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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