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FDA 510(k)

DIGIFOCUS ITE

K-Number: K964683 · 1996-12-12

ApplicantOticon, Inc.
Decision Date1996-12-12
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DIGIFOCUS ITE is the device name listed in this FDA 510(k) record. The listed applicant is Oticon, Inc.. It received FDA 510(k) clearance on 1996-12-12 under 510(k) number K964683. 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 DIGIFOCUS ITE?

DIGIFOCUS ITE is a medical device that received FDA 510(k) clearance on 1996-12-12. The listed applicant is Oticon, Inc.. The 510(k) number is K964683.

When did DIGIFOCUS ITE receive FDA 510(k) clearance?

DIGIFOCUS ITE received FDA 510(k) clearance on 1996-12-12, under 510(k) number K964683.

Who is the listed applicant for DIGIFOCUS ITE?

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

What is the FDA product code for DIGIFOCUS ITE?

The FDA product code for DIGIFOCUS ITE is ESD.

Related Clinical Trials

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Other records listing Oticon, 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.

K973885OTICON DIGISOUND ITEK973886OTICON DIGISOUND COMPACTK961059DIGIFOCUS COMPACTK960284OTICON /PRIMOFOCUS (PF)K954794OTICONK950381OTICON/LOGIC

View all 9 devices →

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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