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FDA 510(k)

OTOSONIC ACS II D WITH SRR

K-Number: K940101 · 1994-04-01

ApplicantBeltone Electronics Corp.
Decision Date1994-04-01
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOSONIC ACS II D WITH SRR 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 1994-04-01 under 510(k) number K940101. 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 II D WITH SRR?

OTOSONIC ACS II D WITH SRR is a medical device that received FDA 510(k) clearance on 1994-04-01. The listed applicant is Beltone Electronics Corp.. The 510(k) number is K940101.

When did OTOSONIC ACS II D WITH SRR receive FDA 510(k) clearance?

OTOSONIC ACS II D WITH SRR received FDA 510(k) clearance on 1994-04-01, under 510(k) number K940101.

Who is the listed applicant for OTOSONIC ACS II D WITH SRR?

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 II D WITH SRR?

The FDA product code for OTOSONIC ACS II D WITH SRR is 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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