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FDA 510(k)

CRAIGWELL MASTER HEARING AID MHA

K-Number: K854126 · 1986-01-16

ApplicantCraigwell Electronics, Ltd.
Decision Date1986-01-16
Product CodeKHL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CRAIGWELL MASTER HEARING AID MHA is the device name listed in this FDA 510(k) record. The listed applicant is Craigwell Electronics, Ltd.. It received FDA 510(k) clearance on 1986-01-16 under 510(k) number K854126. The device is classified under product code KHL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRAIGWELL MASTER HEARING AID MHA?

CRAIGWELL MASTER HEARING AID MHA is a medical device that received FDA 510(k) clearance on 1986-01-16. The listed applicant is Craigwell Electronics, Ltd.. The 510(k) number is K854126.

When did CRAIGWELL MASTER HEARING AID MHA receive FDA 510(k) clearance?

CRAIGWELL MASTER HEARING AID MHA received FDA 510(k) clearance on 1986-01-16, under 510(k) number K854126.

Who is the listed applicant for CRAIGWELL MASTER HEARING AID MHA?

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

What is the FDA product code for CRAIGWELL MASTER HEARING AID MHA?

The FDA product code for CRAIGWELL MASTER HEARING AID MHA is KHL.

Related Clinical Trials

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.

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Other records listing Craigwell Electronics, Ltd. 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.

K854124CRAIGWELL AID HA300K854125CRAIGWELL AID FITTING SYSTEM AFS

Related Devices (Code: KHL)

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.

K964080LORI HEARING AID SIMULATORLori Medical Laboratories, Inc.K911726PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATIONBausch & Lomb, Inc.K894019RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTEResound Corp.K860171VOROBA PROGRAMMABLE AUDITORY COMPARATORVoroba Technologies Assoc.K802812RIONET HEARING AIDKindel & AndersonK790481MODEL FS1Starkey Laboratories, 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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