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FDA 510(k)

LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT

K-Number: K893721 · 1989-09-08

ApplicantLori Medical Laboratories, Inc.
Decision Date1989-09-08
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT 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 1989-09-08 under 510(k) number K893721. 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 LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT?

LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT is a medical device that received FDA 510(k) clearance on 1989-09-08. The listed applicant is Lori Medical Laboratories, Inc.. The 510(k) number is K893721.

When did LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT receive FDA 510(k) clearance?

LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT received FDA 510(k) clearance on 1989-09-08, under 510(k) number K893721.

Who is the listed applicant for LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT?

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-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT?

The FDA product code for LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT is ESD.

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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 IIK964080LORI HEARING AID SIMULATORK952711LORI-AK940639LORI-CIC HEARING AIDK893722LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT

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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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