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)

OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID

K-Number: K893528 · 1989-08-15

ApplicantOticon Corp.
Decision Date1989-08-15
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID is the device name listed in this FDA 510(k) record. The listed applicant is Oticon Corp.. It received FDA 510(k) clearance on 1989-08-15 under 510(k) number K893528. 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 OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID?

OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Oticon Corp.. The 510(k) number is K893528.

When did OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID receive FDA 510(k) clearance?

OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID received FDA 510(k) clearance on 1989-08-15, under 510(k) number K893528.

Who is the listed applicant for OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID?

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

What is the FDA product code for OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID?

The FDA product code for OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG 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 Oticon 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.

K963788PRIMOFOCUS COMPACTK932670OTICON MFK923491BTE HEARING AID PERSONIC 425K923388BTE HEARING AID OTICON MODEL: MULTIFOCUS POWERK923490BTE HEARING AID PERSONIC 410K905555A-ZILICONE

View all 57 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.

↑