FDA 510(k)

INTERACOUSTICS COMPUTER AUDIOMETER BA 20

K-Number: K943066 · 1994-08-24

Decision Date1994-08-24

Product CodeEWO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

INTERACOUSTICS COMPUTER AUDIOMETER BA 20 is the device name listed in this FDA 510(k) record. The listed applicant is Precision Acoustics Ind., Inc.. It received FDA 510(k) clearance on 1994-08-24 under 510(k) number K943066. 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 INTERACOUSTICS COMPUTER AUDIOMETER BA 20?

INTERACOUSTICS COMPUTER AUDIOMETER BA 20 is a medical device that received FDA 510(k) clearance on 1994-08-24. The listed applicant is Precision Acoustics Ind., Inc.. The 510(k) number is K943066.

When did INTERACOUSTICS COMPUTER AUDIOMETER BA 20 receive FDA 510(k) clearance?

INTERACOUSTICS COMPUTER AUDIOMETER BA 20 received FDA 510(k) clearance on 1994-08-24, under 510(k) number K943066.

Who is the listed applicant for INTERACOUSTICS COMPUTER AUDIOMETER BA 20?

The FDA 510(k) record lists Precision Acoustics Ind., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTERACOUSTICS COMPUTER AUDIOMETER BA 20?

The FDA product code for INTERACOUSTICS COMPUTER AUDIOMETER BA 20 is 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.