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FDA 510(k)

AUDIOMETER, RECORDING, AUTOMATIC

K-Number: K772169 · 1977-12-02

ApplicantB&K Instruments, Inc.
Decision Date1977-12-02
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOMETER, RECORDING, AUTOMATIC is the device name listed in this FDA 510(k) record. The listed applicant is B&K Instruments, Inc.. It received FDA 510(k) clearance on 1977-12-02 under 510(k) number K772169. 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 AUDIOMETER, RECORDING, AUTOMATIC?

AUDIOMETER, RECORDING, AUTOMATIC is a medical device that received FDA 510(k) clearance on 1977-12-02. The listed applicant is B&K Instruments, Inc.. The 510(k) number is K772169.

When did AUDIOMETER, RECORDING, AUTOMATIC receive FDA 510(k) clearance?

AUDIOMETER, RECORDING, AUTOMATIC received FDA 510(k) clearance on 1977-12-02, under 510(k) number K772169.

Who is the listed applicant for AUDIOMETER, RECORDING, AUTOMATIC?

The FDA 510(k) record lists B&K Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUDIOMETER, RECORDING, AUTOMATIC?

The FDA product code for AUDIOMETER, RECORDING, AUTOMATIC is EWO.

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Related Devices (Code: EWO)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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