FDA 510(k)

Z35

K-Number: K953051 · 1995-08-15

Decision Date1995-08-15

Product CodeESD

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Z35 is the device name listed in this FDA 510(k) record. The listed applicant is Electone, Inc.. It received FDA 510(k) clearance on 1995-08-15 under 510(k) number K953051. 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 Z35?

Z35 is a medical device that received FDA 510(k) clearance on 1995-08-15. The listed applicant is Electone, Inc.. The 510(k) number is K953051.

When did Z35 receive FDA 510(k) clearance?

Z35 received FDA 510(k) clearance on 1995-08-15, under 510(k) number K953051.

Who is the listed applicant for Z35?

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 Z35?

The FDA product code for Z35 is ESD.

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-II K961084AM 400 K955702SONATA U-01 K953050Z33 K953047Z20 K953054AM 260 OHM

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Related Devices (Code: ESD)

K232999Lyric4 Hearing AidSonova AG K130790LYRIC2Phonak, LLC K081136LYRIC 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.