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FDA 510(k)

MODEL UM IN-THE-CANAL HEARING AID

K-Number: K862101 · 1986-06-23

ApplicantMiracle-Ear/Dahlberg, Inc.
Decision Date1986-06-23
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL UM IN-THE-CANAL HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Miracle-Ear/Dahlberg, Inc.. It received FDA 510(k) clearance on 1986-06-23 under 510(k) number K862101. 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 MODEL UM IN-THE-CANAL HEARING AID?

MODEL UM IN-THE-CANAL HEARING AID is a medical device that received FDA 510(k) clearance on 1986-06-23. The listed applicant is Miracle-Ear/Dahlberg, Inc.. The 510(k) number is K862101.

When did MODEL UM IN-THE-CANAL HEARING AID receive FDA 510(k) clearance?

MODEL UM IN-THE-CANAL HEARING AID received FDA 510(k) clearance on 1986-06-23, under 510(k) number K862101.

Who is the listed applicant for MODEL UM IN-THE-CANAL HEARING AID?

The FDA 510(k) record lists Miracle-Ear/Dahlberg, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL UM IN-THE-CANAL HEARING AID?

The FDA product code for MODEL UM IN-THE-CANAL HEARING AID is ESD.

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Other records listing Miracle-Ear/Dahlberg, 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.

K942895MIRACLE EAR MODEL PGMK942893MIRACLE-EAR MODEL PGF + REMOTEK942894MIRACLE-EAR MODEL PGCK941859MIRACLE-EAR EAR IMPRESSION MATERIALK862104MODEL UC SPECTRUM IN-THE-CANAL HEARING AIDK862099DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID

View all 23 devices →

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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