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FDA 510(k)

OTOSONIC ACS-IC

K-Number: K922224 · 1992-05-27

ApplicantBeltone Electronics Corp.
Decision Date1992-05-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOSONIC ACS-IC 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 1992-05-27 under 510(k) number K922224. 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 OTOSONIC ACS-IC?

OTOSONIC ACS-IC is a medical device that received FDA 510(k) clearance on 1992-05-27. The listed applicant is Beltone Electronics Corp.. The 510(k) number is K922224.

When did OTOSONIC ACS-IC receive FDA 510(k) clearance?

OTOSONIC ACS-IC received FDA 510(k) clearance on 1992-05-27, under 510(k) number K922224.

Who is the listed applicant for OTOSONIC ACS-IC?

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 OTOSONIC ACS-IC?

The FDA product code for OTOSONIC ACS-IC is ESD.

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Other records listing Beltone Electronics Corp. as applicant

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Related Devices (Code: ESD)

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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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