Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LORI-A

K-Number: K952711 · 1995-07-03

ApplicantLori Medical Laboratories, Inc.
Decision Date1995-07-03
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LORI-A 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 1995-07-03 under 510(k) number K952711. 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-A?

LORI-A is a medical device that received FDA 510(k) clearance on 1995-07-03. The listed applicant is Lori Medical Laboratories, Inc.. The 510(k) number is K952711.

When did LORI-A receive FDA 510(k) clearance?

LORI-A received FDA 510(k) clearance on 1995-07-03, under 510(k) number K952711.

Who is the listed applicant for LORI-A?

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-A?

The FDA product code for LORI-A is ESD.

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 SIMULATORK940639LORI-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: 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.

↑