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FDA 510(k)

HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL

K-Number: K963607 · 1996-09-20

ApplicantMidwest City Hearing Aid Center
Decision Date1996-09-20
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL is the device name listed in this FDA 510(k) record. The listed applicant is Midwest City Hearing Aid Center. It received FDA 510(k) clearance on 1996-09-20 under 510(k) number K963607. 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 HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL?

HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL is a medical device that received FDA 510(k) clearance on 1996-09-20. The listed applicant is Midwest City Hearing Aid Center. The 510(k) number is K963607.

When did HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL receive FDA 510(k) clearance?

HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL received FDA 510(k) clearance on 1996-09-20, under 510(k) number K963607.

Who is the listed applicant for HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL?

The FDA 510(k) record lists Midwest City Hearing Aid Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL?

The FDA product code for HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL is ESD.

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Other records listing Midwest City Hearing Aid Center 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.

K970430ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCIK963604DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSIONK953728RX12 LINEAR FULL SHELL AND IN THE CANALK953729K AMP FULL SHELL AND IN THE EARK953631SNIP INPUT COMPRESSION CLASS AK952986SPI-SECRET PERSONAL INSTRUMENT CIC

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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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