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FDA 510(k)

FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10

K-Number: K862768 · 1986-08-13

ApplicantMaico Hearing Instruments, Inc.
Decision Date1986-08-13
Product CodeLRB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10 is the device name listed in this FDA 510(k) record. The listed applicant is Maico Hearing Instruments, Inc.. It received FDA 510(k) clearance on 1986-08-13 under 510(k) number K862768. The device is classified under product code LRB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10?

FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10 is a medical device that received FDA 510(k) clearance on 1986-08-13. The listed applicant is Maico Hearing Instruments, Inc.. The 510(k) number is K862768.

When did FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10 receive FDA 510(k) clearance?

FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10 received FDA 510(k) clearance on 1986-08-13, under 510(k) number K862768.

Who is the listed applicant for FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10?

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

What is the FDA product code for FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10?

The FDA product code for FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10 is LRB.

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Other records listing Maico Hearing Instruments, 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.

K960031AUDIOFLEX 120K954054MAICO PRODIGY CIC SERIESK953161MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTIONK950637MAICO IN-THE-EAR MODEL RD-312 CICK946253MAICO IN-THE-EAR MODEL RD 201K931322KS 5 - CLINICAL AUDIOMETER

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Related Devices (Code: LRB)

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.

K974219FACEPLATE ASSEMBLYFinetone Hearing InstrumentsK961593INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDSSegi Hearing Aid Co.K942722MODULE PROGRAMElectone, Inc.K942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)Audina Hearing InstrumentK935048ARTISAN PROGRAMMER & HEARING AIDTelex Communications, Inc.K933045SILVER RECHARGEABLE MODULE, ITEElectone, 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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