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FDA 510(k)

BELTONE ULTIMA 80 OTOSONIC POWER PAS

K-Number: K954936 · 1995-12-06

ApplicantBeltone Electronics Corp.
Decision Date1995-12-06
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BELTONE ULTIMA 80 OTOSONIC POWER PAS is the device name listed in this FDA 510(k) record. The listed applicant is Beltone Electronics Corp.. It received FDA 510(k) clearance on 1995-12-06 under 510(k) number K954936. 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 BELTONE ULTIMA 80 OTOSONIC POWER PAS?

BELTONE ULTIMA 80 OTOSONIC POWER PAS is a medical device that received FDA 510(k) clearance on 1995-12-06. The listed applicant is Beltone Electronics Corp.. The 510(k) number is K954936.

When did BELTONE ULTIMA 80 OTOSONIC POWER PAS receive FDA 510(k) clearance?

BELTONE ULTIMA 80 OTOSONIC POWER PAS received FDA 510(k) clearance on 1995-12-06, under 510(k) number K954936.

Who is the listed applicant for BELTONE ULTIMA 80 OTOSONIC POWER PAS?

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

What is the FDA product code for BELTONE ULTIMA 80 OTOSONIC POWER PAS?

The FDA product code for BELTONE ULTIMA 80 OTOSONIC POWER PAS is ESD.

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Other records listing Beltone Electronics 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.

K971852AIR CONDUCTION HAEARING AIDSK963958IMPRESS, PERFECTA, ACU-FORM, AND ACUFITK955930BELTONE COMPOSER 2000 BTE HPK943616BELTONE PERSONAL HEARING SCREENERK951587BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE KK952097OTOSONIC (OSI) CF 10-K, 10-D

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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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