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FDA 510(k)

MODEL AUDINA ITE HEATING AID

K-Number: K897024 · 1990-04-18

ApplicantAudina Hearing Instrument
Decision Date1990-04-18
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL AUDINA ITE HEATING AID is the device name listed in this FDA 510(k) record. The listed applicant is Audina Hearing Instrument. It received FDA 510(k) clearance on 1990-04-18 under 510(k) number K897024. 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 MODEL AUDINA ITE HEATING AID?

MODEL AUDINA ITE HEATING AID is a medical device that received FDA 510(k) clearance on 1990-04-18. The listed applicant is Audina Hearing Instrument. The 510(k) number is K897024.

When did MODEL AUDINA ITE HEATING AID receive FDA 510(k) clearance?

MODEL AUDINA ITE HEATING AID received FDA 510(k) clearance on 1990-04-18, under 510(k) number K897024.

Who is the listed applicant for MODEL AUDINA ITE HEATING AID?

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

What is the FDA product code for MODEL AUDINA ITE HEATING AID?

The FDA product code for MODEL AUDINA ITE HEATING AID 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 Audina Hearing Instrument 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.

K964816AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EARK953960HEARING AID (ALL-IN-THE-EAR)K942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)K936190BEHIND THE EAR HEARING AIDK930271BEHIND-THE-EAR HEARING AIDK897023OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID

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.

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