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FDA 510(k)

OE SERIES OF BEHIND-THE-EAR HEARING AIDS

K-Number: K853381 · 1985-11-08

ApplicantEmtech Laboratories
Decision Date1985-11-08
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OE SERIES OF BEHIND-THE-EAR HEARING AIDS is the device name listed in this FDA 510(k) record. The listed applicant is Emtech Laboratories. It received FDA 510(k) clearance on 1985-11-08 under 510(k) number K853381. 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 OE SERIES OF BEHIND-THE-EAR HEARING AIDS?

OE SERIES OF BEHIND-THE-EAR HEARING AIDS is a medical device that received FDA 510(k) clearance on 1985-11-08. The listed applicant is Emtech Laboratories. The 510(k) number is K853381.

When did OE SERIES OF BEHIND-THE-EAR HEARING AIDS receive FDA 510(k) clearance?

OE SERIES OF BEHIND-THE-EAR HEARING AIDS received FDA 510(k) clearance on 1985-11-08, under 510(k) number K853381.

Who is the listed applicant for OE SERIES OF BEHIND-THE-EAR HEARING AIDS?

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

What is the FDA product code for OE SERIES OF BEHIND-THE-EAR HEARING AIDS?

The FDA product code for OE SERIES OF BEHIND-THE-EAR HEARING AIDS is ESD.

Related Clinical Trials

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.

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Other records listing Emtech Laboratories 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.

K962292HEARSAVER

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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