ALPHA STEREO— 510(k) K934478

Substantially Equivalent

Instrumentarium Corp.

FDA 510(k) clearance K934478 for ALPHA STEREO, Substantially Equivalent on 1995-01-31. Applicant: Instrumentarium Corp.. Device class: 2.

Clearance details

Applicant: Instrumentarium Corp.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1993-09-14
Decision date: 1995-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuusula, Finland, FI

Download summary PDF View on FDA.gov ↗

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