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FDA 510(k)

DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER

K-Number: K854835 · 1986-03-04

ApplicantMiracle-Ear/Dahlberg, Inc.
Decision Date1986-03-04
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Miracle-Ear/Dahlberg, Inc.. It received FDA 510(k) clearance on 1986-03-04 under 510(k) number K854835. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER?

DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER is a medical device that received FDA 510(k) clearance on 1986-03-04. The listed applicant is Miracle-Ear/Dahlberg, Inc.. The 510(k) number is K854835.

When did DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER receive FDA 510(k) clearance?

DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER received FDA 510(k) clearance on 1986-03-04, under 510(k) number K854835.

Who is the listed applicant for DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER?

The FDA 510(k) record lists Miracle-Ear/Dahlberg, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER?

The FDA product code for DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER is EWO.

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Related Devices (Code: EWO)

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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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