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)

RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION

K-Number: K951379 · 1995-04-27

ApplicantResound Corp.
Decision Date1995-04-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Resound Corp.. It received FDA 510(k) clearance on 1995-04-27 under 510(k) number K951379. 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 RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION?

RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION is a medical device that received FDA 510(k) clearance on 1995-04-27. The listed applicant is Resound Corp.. The 510(k) number is K951379.

When did RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION receive FDA 510(k) clearance?

RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION received FDA 510(k) clearance on 1995-04-27, under 510(k) number K951379.

Who is the listed applicant for RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION?

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

What is the FDA product code for RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION?

The FDA product code for RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION 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 Resound Corp. 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.

K984547DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDSK974081RESOUND STEALTH CICK974257RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)K971605RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTIONK970215AUDALLION II HEARING SYSTEMK964557RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION

View all 41 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.

↑