EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)— 510(k) K983660

Name: FDA 510(k) clearance K983660
Creator: U.S. Food and Drug Administration
Published: 1999-07-14

Substantially Equivalent

Brainlab, Inc.

FDA 510(k) clearance K983660 for EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM), Substantially Equivalent on 1999-07-14. Applicant: Brainlab, Inc.. Device class: 2.

Clearance details

Applicant: Brainlab, Inc.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 1998-10-19
Decision date: 1999-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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