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FDA 510(k)

IAI PROGRAM-COMPUTER PROGRAM

K-Number: K844997 · 1985-04-09

ApplicantIntl. Acoustics, Inc.
Decision Date1985-04-09
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IAI PROGRAM-COMPUTER PROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Acoustics, Inc.. It received FDA 510(k) clearance on 1985-04-09 under 510(k) number K844997. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IAI PROGRAM-COMPUTER PROGRAM?

IAI PROGRAM-COMPUTER PROGRAM is a medical device that received FDA 510(k) clearance on 1985-04-09. The listed applicant is Intl. Acoustics, Inc.. The 510(k) number is K844997.

When did IAI PROGRAM-COMPUTER PROGRAM receive FDA 510(k) clearance?

IAI PROGRAM-COMPUTER PROGRAM received FDA 510(k) clearance on 1985-04-09, under 510(k) number K844997.

Who is the listed applicant for IAI PROGRAM-COMPUTER PROGRAM?

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

What is the FDA product code for IAI PROGRAM-COMPUTER PROGRAM?

The FDA product code for IAI PROGRAM-COMPUTER PROGRAM is DXG.

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Other records listing Intl. Acoustics, Inc. as applicant

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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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