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FDA 510(k)

HF MEGA EAR

K-Number: K960567 · 1996-10-16

ApplicantMaxi-Aids, Inc.
Decision Date1996-10-16
Product CodeEPF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HF MEGA EAR is the device name listed in this FDA 510(k) record. The listed applicant is Maxi-Aids, Inc.. It received FDA 510(k) clearance on 1996-10-16 under 510(k) number K960567. 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 HF MEGA EAR?

HF MEGA EAR is a medical device that received FDA 510(k) clearance on 1996-10-16. The listed applicant is Maxi-Aids, Inc.. The 510(k) number is K960567.

When did HF MEGA EAR receive FDA 510(k) clearance?

HF MEGA EAR received FDA 510(k) clearance on 1996-10-16, under 510(k) number K960567.

Who is the listed applicant for HF MEGA EAR?

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

What is the FDA product code for HF MEGA EAR?

The FDA product code for HF MEGA EAR is EPF.

Other records listing Maxi-Aids, 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.

K041778REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T

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.K970687WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK970665WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK950730GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)Phonic Ear, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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