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)

FINETONE DISCEET CANAL

K-Number: K945780 · 1994-12-21

ApplicantFinetone Hearing Instruments
Decision Date1994-12-21
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FINETONE DISCEET CANAL is the device name listed in this FDA 510(k) record. The listed applicant is Finetone Hearing Instruments. It received FDA 510(k) clearance on 1994-12-21 under 510(k) number K945780. 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 FINETONE DISCEET CANAL?

FINETONE DISCEET CANAL is a medical device that received FDA 510(k) clearance on 1994-12-21. The listed applicant is Finetone Hearing Instruments. The 510(k) number is K945780.

When did FINETONE DISCEET CANAL receive FDA 510(k) clearance?

FINETONE DISCEET CANAL received FDA 510(k) clearance on 1994-12-21, under 510(k) number K945780.

Who is the listed applicant for FINETONE DISCEET CANAL?

The FDA 510(k) record lists Finetone Hearing Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FINETONE DISCEET CANAL?

The FDA product code for FINETONE DISCEET CANAL is ESD.

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 Finetone Hearing Instruments 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.

K974219FACEPLATE ASSEMBLYK955692FINETONE FSC,K940164SUPER-SILK830960CUSTOM IN-THE-EAR HEARING AID

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.

↑