ALPHA II DIAGNOSTIC X-RAY— 510(k) K864958

Substantially Equivalent

Ausonics Pty , Ltd.

FDA 510(k) clearance K864958 for ALPHA II DIAGNOSTIC X-RAY, Substantially Equivalent on 1987-01-30. Applicant: Ausonics Pty , Ltd.. Device class: 2.

Clearance details

Applicant: Ausonics Pty , Ltd.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1986-12-18
Decision date: 1987-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suffield, CT, US

Download summary PDF View on FDA.gov ↗

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K905488 — DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN1991-12-18
K902728 — 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)1991-02-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.