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)

MODULE PROGRAM

K-Number: K942722 · 1994-09-06

ApplicantElectone, Inc.
Decision Date1994-09-06
Product CodeLRB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODULE PROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Electone, Inc.. It received FDA 510(k) clearance on 1994-09-06 under 510(k) number K942722. 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 MODULE PROGRAM?

MODULE PROGRAM is a medical device that received FDA 510(k) clearance on 1994-09-06. The listed applicant is Electone, Inc.. The 510(k) number is K942722.

When did MODULE PROGRAM receive FDA 510(k) clearance?

MODULE PROGRAM received FDA 510(k) clearance on 1994-09-06, under 510(k) number K942722.

Who is the listed applicant for MODULE PROGRAM?

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

What is the FDA product code for MODULE PROGRAM?

The FDA product code for MODULE PROGRAM is LRB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Electone, 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.

K973266Z DEQ-IIK961084AM 400K955702SONATA U-01K953047Z20K953050Z33K953051Z35

View all 73 devices →

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.K942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)Audina Hearing InstrumentK935048ARTISAN PROGRAMMER & HEARING AIDTelex Communications, Inc.K933039GOLD L MODULE, ITEElectone, Inc.K933046SILVER L 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.

↑