FDA 510(k)

770-ATC

K-Number: K941133 · 1994-05-12

Decision Date1994-05-12

Product CodeESD

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

770-ATC is the device name listed in this FDA 510(k) record. The listed applicant is Electone, Inc.. It received FDA 510(k) clearance on 1994-05-12 under 510(k) number K941133. 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 770-ATC?

770-ATC is a medical device that received FDA 510(k) clearance on 1994-05-12. The listed applicant is Electone, Inc.. The 510(k) number is K941133.

When did 770-ATC receive FDA 510(k) clearance?

770-ATC received FDA 510(k) clearance on 1994-05-12, under 510(k) number K941133.

Who is the listed applicant for 770-ATC?

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 770-ATC?

The FDA product code for 770-ATC 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 K953047Z20 K953050Z33 K953051Z35

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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.