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FDA 510(k)

IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823

K-Number: K862086 · 1986-07-16

ApplicantA/S Bruel & Kjaer
Decision Date1986-07-16
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823 is the device name listed in this FDA 510(k) record. The listed applicant is A/S Bruel & Kjaer. It received FDA 510(k) clearance on 1986-07-16 under 510(k) number K862086. The device is classified under product code ETW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823?

IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823 is a medical device that received FDA 510(k) clearance on 1986-07-16. The listed applicant is A/S Bruel & Kjaer. The 510(k) number is K862086.

When did IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823 receive FDA 510(k) clearance?

IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823 received FDA 510(k) clearance on 1986-07-16, under 510(k) number K862086.

Who is the listed applicant for IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823?

The FDA 510(k) record lists A/S Bruel & Kjaer as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823?

The FDA product code for IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823 is ETW.

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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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