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FDA 510(k)

MIRACLE-EAR EAR IMPRESSION MATERIAL

K-Number: K941859 · 1994-07-25

ApplicantMiracle-Ear/Dahlberg, Inc.
Decision Date1994-07-25
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MIRACLE-EAR EAR IMPRESSION MATERIAL 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 1994-07-25 under 510(k) number K941859. 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 MIRACLE-EAR EAR IMPRESSION MATERIAL?

MIRACLE-EAR EAR IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1994-07-25. The listed applicant is Miracle-Ear/Dahlberg, Inc.. The 510(k) number is K941859.

When did MIRACLE-EAR EAR IMPRESSION MATERIAL receive FDA 510(k) clearance?

MIRACLE-EAR EAR IMPRESSION MATERIAL received FDA 510(k) clearance on 1994-07-25, under 510(k) number K941859.

Who is the listed applicant for MIRACLE-EAR EAR IMPRESSION MATERIAL?

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 MIRACLE-EAR EAR IMPRESSION MATERIAL?

The FDA product code for MIRACLE-EAR EAR IMPRESSION MATERIAL 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 PGCK862101MODEL UM IN-THE-CANAL HEARING AIDK862104MODEL UC SPECTRUM IN-THE-CANAL HEARING AIDK862100MODEL ED BEHIND-THE-EAR HEARING AID

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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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