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FDA 510(k)

PE 400IR, PE 400T, PE 400E

K-Number: K923234 · 1992-09-29

ApplicantPhonic Ear, Inc.
Decision Date1992-09-29
Product CodeEPF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PE 400IR, PE 400T, PE 400E 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 1992-09-29 under 510(k) number K923234. The device is classified under product code EPF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PE 400IR, PE 400T, PE 400E?

PE 400IR, PE 400T, PE 400E is a medical device that received FDA 510(k) clearance on 1992-09-29. The listed applicant is Phonic Ear, Inc.. The 510(k) number is K923234.

When did PE 400IR, PE 400T, PE 400E receive FDA 510(k) clearance?

PE 400IR, PE 400T, PE 400E received FDA 510(k) clearance on 1992-09-29, under 510(k) number K923234.

Who is the listed applicant for PE 400IR, PE 400T, PE 400E?

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 PE 400IR, PE 400T, PE 400E?

The FDA product code for PE 400IR, PE 400T, PE 400E is EPF.

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 EARK922720GROUP AUDITORY TRAINING SYSTEM

View all 31 devices →

Related Devices (Code: EPF)

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.

K982683TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONTelex Communications, Inc.K974658INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, ITPhonic Ear, Inc.K974287FM RECEIVER - AUDITORY TRAINERPhonic Ear, Inc.K970665WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK970687WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK960567HF MEGA EARMaxi-Aids, 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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