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FDA 510(k)

ITE HEARING AID, SOUND MED RUBY MODEL

K-Number: K903862 · 1990-10-09

ApplicantImproved Hearing Service, Inc.
Decision Date1990-10-09
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ITE HEARING AID, SOUND MED RUBY MODEL is the device name listed in this FDA 510(k) record. The listed applicant is Improved Hearing Service, Inc.. It received FDA 510(k) clearance on 1990-10-09 under 510(k) number K903862. 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 ITE HEARING AID, SOUND MED RUBY MODEL?

ITE HEARING AID, SOUND MED RUBY MODEL is a medical device that received FDA 510(k) clearance on 1990-10-09. The listed applicant is Improved Hearing Service, Inc.. The 510(k) number is K903862.

When did ITE HEARING AID, SOUND MED RUBY MODEL receive FDA 510(k) clearance?

ITE HEARING AID, SOUND MED RUBY MODEL received FDA 510(k) clearance on 1990-10-09, under 510(k) number K903862.

Who is the listed applicant for ITE HEARING AID, SOUND MED RUBY MODEL?

The FDA 510(k) record lists Improved Hearing Service, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ITE HEARING AID, SOUND MED RUBY MODEL?

The FDA product code for ITE HEARING AID, SOUND MED RUBY MODEL 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 Improved Hearing Service, Inc. 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.

K903864ITE HEARING AID, PEARL MODELK903865ITE HEARING AID, SOUND MED AMETHYST MODELK903861ITE HEARING AID, SOUND MED GOLDEN NUGGET MODELK903860ITE HEARING AID, SAAPHIRE MODELK903415ITE HEARING AID, SOUND MED EMERALD MODELK903863ITE HEARING AID, SOUND MED OPAL MODEL

View all 9 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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