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FDA 510(k)

LORI HEARING AID SIMULATOR

K-Number: K964080 · 1997-01-08

ApplicantLori Medical Laboratories, Inc.
Decision Date1997-01-08
Product CodeKHL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LORI HEARING AID SIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Lori Medical Laboratories, Inc.. It received FDA 510(k) clearance on 1997-01-08 under 510(k) number K964080. 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 LORI HEARING AID SIMULATOR?

LORI HEARING AID SIMULATOR is a medical device that received FDA 510(k) clearance on 1997-01-08. The listed applicant is Lori Medical Laboratories, Inc.. The 510(k) number is K964080.

When did LORI HEARING AID SIMULATOR receive FDA 510(k) clearance?

LORI HEARING AID SIMULATOR received FDA 510(k) clearance on 1997-01-08, under 510(k) number K964080.

Who is the listed applicant for LORI HEARING AID SIMULATOR?

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

What is the FDA product code for LORI HEARING AID SIMULATOR?

The FDA product code for LORI HEARING AID SIMULATOR 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 Lori Medical Laboratories, 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.

K973376LORI/LORI, LORI-S (LORI STOCK AID)K972058LORIPRO, LORIPRO IIK952711LORI-AK940639LORI-CIC HEARING AIDK893721LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENTK893723LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT

View all 8 devices →

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.

K911726PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATIONBausch & Lomb, Inc.K894019RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTEResound Corp.K860171VOROBA PROGRAMMABLE AUDITORY COMPARATORVoroba Technologies Assoc.K854126CRAIGWELL MASTER HEARING AID MHACraigwell Electronics, Ltd.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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