PARALLAX CRANIOSET— 510(k) K994022

Substantially Equivalent

Parallax Medical, Inc.

FDA 510(k) clearance K994022 for PARALLAX CRANIOSET, Substantially Equivalent on 2000-08-31. Applicant: Parallax Medical, Inc.. Device class: 2.

Clearance details

Applicant: Parallax Medical, Inc.
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 1999-11-26
Decision date: 2000-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Parallax Medical, Inc.

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K011206 — PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES2001-07-18
K991893 — PARALLAX TRACER RADIOPAQUE PARTICLES1999-08-13

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