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FDA 510(k)

OPTIMA WITH DELTA AMP

K-Number: K942213 · 1994-06-17

ApplicantBeltone Electronics Corp.
Decision Date1994-06-17
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OPTIMA WITH DELTA AMP 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 1994-06-17 under 510(k) number K942213. 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 OPTIMA WITH DELTA AMP?

OPTIMA WITH DELTA AMP is a medical device that received FDA 510(k) clearance on 1994-06-17. The listed applicant is Beltone Electronics Corp.. The 510(k) number is K942213.

When did OPTIMA WITH DELTA AMP receive FDA 510(k) clearance?

OPTIMA WITH DELTA AMP received FDA 510(k) clearance on 1994-06-17, under 510(k) number K942213.

Who is the listed applicant for OPTIMA WITH DELTA AMP?

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 OPTIMA WITH DELTA AMP?

The FDA product code for OPTIMA WITH DELTA AMP 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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