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)

EXPANDER WITH ACTIVE TONE CONTROL

K-Number: K952454 · 1995-06-21

ApplicantArgosy Electronics
Decision Date1995-06-21
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EXPANDER WITH ACTIVE TONE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Argosy Electronics. It received FDA 510(k) clearance on 1995-06-21 under 510(k) number K952454. 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 EXPANDER WITH ACTIVE TONE CONTROL?

EXPANDER WITH ACTIVE TONE CONTROL is a medical device that received FDA 510(k) clearance on 1995-06-21. The listed applicant is Argosy Electronics. The 510(k) number is K952454.

When did EXPANDER WITH ACTIVE TONE CONTROL receive FDA 510(k) clearance?

EXPANDER WITH ACTIVE TONE CONTROL received FDA 510(k) clearance on 1995-06-21, under 510(k) number K952454.

Who is the listed applicant for EXPANDER WITH ACTIVE TONE CONTROL?

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

What is the FDA product code for EXPANDER WITH ACTIVE TONE CONTROL?

The FDA product code for EXPANDER WITH ACTIVE TONE CONTROL 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 Argosy Electronics 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.

K974242ARGOSY PROGRAMMABLE ONQUEK971699ARGOSY DYNAMEQK961729ARGOSY PROGRAMMABLEK954038K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENTK952451CLASS D LINEAR WITH ACTIVE TONE CONTROLK952450WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL

View all 24 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.

↑