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FDA 510(k)

PHONIC EAR MODELS PE 811CS AND PE 811CST

K-Number: K864672 · 1987-02-20

ApplicantPhonic Ear, Inc.
Decision Date1987-02-20
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PHONIC EAR MODELS PE 811CS AND PE 811CST 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 1987-02-20 under 510(k) number K864672. 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 MODELS PE 811CS AND PE 811CST?

PHONIC EAR MODELS PE 811CS AND PE 811CST is a medical device that received FDA 510(k) clearance on 1987-02-20. The listed applicant is Phonic Ear, Inc.. The 510(k) number is K864672.

When did PHONIC EAR MODELS PE 811CS AND PE 811CST receive FDA 510(k) clearance?

PHONIC EAR MODELS PE 811CS AND PE 811CST received FDA 510(k) clearance on 1987-02-20, under 510(k) number K864672.

Who is the listed applicant for PHONIC EAR MODELS PE 811CS AND PE 811CST?

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 MODELS PE 811CS AND PE 811CST?

The FDA product code for PHONIC EAR MODELS PE 811CS AND PE 811CST 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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