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FDA 510(k)

BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP

K-Number: K931157 · 1993-04-14

ApplicantTelex Communications, Inc.
Decision Date1993-04-14
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP is the device name listed in this FDA 510(k) record. The listed applicant is Telex Communications, Inc.. It received FDA 510(k) clearance on 1993-04-14 under 510(k) number K931157. 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 BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP?

BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP is a medical device that received FDA 510(k) clearance on 1993-04-14. The listed applicant is Telex Communications, Inc.. The 510(k) number is K931157.

When did BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP receive FDA 510(k) clearance?

BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP received FDA 510(k) clearance on 1993-04-14, under 510(k) number K931157.

Who is the listed applicant for BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP?

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

What is the FDA product code for BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP?

The FDA product code for BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP is ESD.

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Other records listing Telex Communications, 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.

K984243TELEX TINNITUS-COMPANIONK982683TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONK964639TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-IIK963915TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSIONK961143TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40K954579TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION

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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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