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)

MODULAR HEARING DEVICE, MODEL S291

K-Number: K771762 · 1977-10-04

ApplicantVicon Instrument Co.
Decision Date1977-10-04
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODULAR HEARING DEVICE, MODEL S291 is the device name listed in this FDA 510(k) record. The listed applicant is Vicon Instrument Co.. It received FDA 510(k) clearance on 1977-10-04 under 510(k) number K771762. 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 MODULAR HEARING DEVICE, MODEL S291?

MODULAR HEARING DEVICE, MODEL S291 is a medical device that received FDA 510(k) clearance on 1977-10-04. The listed applicant is Vicon Instrument Co.. The 510(k) number is K771762.

When did MODULAR HEARING DEVICE, MODEL S291 receive FDA 510(k) clearance?

MODULAR HEARING DEVICE, MODEL S291 received FDA 510(k) clearance on 1977-10-04, under 510(k) number K771762.

Who is the listed applicant for MODULAR HEARING DEVICE, MODEL S291?

The FDA 510(k) record lists Vicon Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODULAR HEARING DEVICE, MODEL S291?

The FDA product code for MODULAR HEARING DEVICE, MODEL S291 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 Vicon Instrument Co. 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.

K811751FINETONE MODEL VI HEARING AIDK790878SCREENING AUDIOMETER, HIGH FREQUENCYK790064TINNITUS DEVICESK771769TINNITUS MASKERS, MODELS S564&S574K770938TINNITUS AID, MODEL S244K761216HEARING AIDS (MODEL E-552 S-712)

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.

↑