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FDA 510(k)

LIFESOUND CUSTOM ITE

K-Number: K862050 · 1986-06-23

ApplicantLifesounds, Inc.
Decision Date1986-06-23
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LIFESOUND CUSTOM ITE is the device name listed in this FDA 510(k) record. The listed applicant is Lifesounds, Inc.. It received FDA 510(k) clearance on 1986-06-23 under 510(k) number K862050. 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 LIFESOUND CUSTOM ITE?

LIFESOUND CUSTOM ITE is a medical device that received FDA 510(k) clearance on 1986-06-23. The listed applicant is Lifesounds, Inc.. The 510(k) number is K862050.

When did LIFESOUND CUSTOM ITE receive FDA 510(k) clearance?

LIFESOUND CUSTOM ITE received FDA 510(k) clearance on 1986-06-23, under 510(k) number K862050.

Who is the listed applicant for LIFESOUND CUSTOM ITE?

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

What is the FDA product code for LIFESOUND CUSTOM ITE?

The FDA product code for LIFESOUND CUSTOM ITE is ESD.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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