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FDA 510(k)

SONATA U-01

K-Number: K955702 · 1996-02-22

ApplicantElectone, Inc.
Decision Date1996-02-22
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SONATA U-01 is the device name listed in this FDA 510(k) record. The listed applicant is Electone, Inc.. It received FDA 510(k) clearance on 1996-02-22 under 510(k) number K955702. 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 SONATA U-01?

SONATA U-01 is a medical device that received FDA 510(k) clearance on 1996-02-22. The listed applicant is Electone, Inc.. The 510(k) number is K955702.

When did SONATA U-01 receive FDA 510(k) clearance?

SONATA U-01 received FDA 510(k) clearance on 1996-02-22, under 510(k) number K955702.

Who is the listed applicant for SONATA U-01?

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

What is the FDA product code for SONATA U-01?

The FDA product code for SONATA U-01 is ESD.

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Other records listing Electone, 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.

K973266Z DEQ-IIK961084AM 400K953050Z33K953047Z20K953051Z35K953054AM 260 OHM

View all 73 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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