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FDA 510(k)

PHONIC EAR

K-Number: K861857 · 1986-06-09

ApplicantPhonic Ear, Inc.
Decision Date1986-06-09
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PHONIC EAR 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 1986-06-09 under 510(k) number K861857. The device is classified under product code ETW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHONIC EAR?

PHONIC EAR is a medical device that received FDA 510(k) clearance on 1986-06-09. The listed applicant is Phonic Ear, Inc.. The 510(k) number is K861857.

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

PHONIC EAR received FDA 510(k) clearance on 1986-06-09, under 510(k) number K861857.

Who is the listed applicant for PHONIC EAR?

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?

The FDA product code for PHONIC EAR is ETW.

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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: ETW)

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.

K122028AURICAL HITGn OtometricsK113831PRIMUS HEARING INSTRUMENT TEST UNITAuditdata A/SK110286GN OTOMETRICS TYPE 1053 FREEFITGn Otometrics A/SK093006FONIX ,MODEL 8000Frye Electronics, Inc.K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)Siemens Hearing Instruments, Inc.K061104SPEECHLINK 100 TYPE 1053Gn Otometrics A/S

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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