IAI PROGRAM-COMPUTER PROGRAM— 510(k) K844997

Name: FDA 510(k) clearance K844997
Creator: U.S. Food and Drug Administration
Published: 1985-04-09

Substantially Equivalent

Intl. Acoustics, Inc.

FDA 510(k) clearance K844997 for IAI PROGRAM-COMPUTER PROGRAM, Substantially Equivalent on 1985-04-09. Applicant: Intl. Acoustics, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Acoustics, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1984-12-26
Decision date: 1985-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palatine, IL, US

Download summary PDF View on FDA.gov ↗

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