DSP100 CAROTID PHONOANGIOGRAPHY MODULE— 510(k) K864429

Name: FDA 510(k) clearance K864429
Creator: U.S. Food and Drug Administration
Published: 1987-05-12

Substantially Equivalent

Intl. Acoustics, Inc.

FDA 510(k) clearance K864429 for DSP100 CAROTID PHONOANGIOGRAPHY MODULE, Substantially Equivalent on 1987-05-12. Applicant: Intl. Acoustics, Inc.. Device class: 1.

Clearance details

Applicant: Intl. Acoustics, Inc.
Product code: Code DQC
Device class: Class 1
Regulation: 21 CFR 870.2390
Advisory panel: Cardiovascular
Date received: 1986-11-12
Decision date: 1987-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palatine, IL, US

Download summary PDF View on FDA.gov ↗

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K873640 — MODIFIED DSP100 AMPLIFIER1987-12-07
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K844997 — IAI PROGRAM-COMPUTER PROGRAM1985-04-09

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