VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX— 510(k) K011702

Name: FDA 510(k) clearance K011702
Creator: U.S. Food and Drug Administration
Published: 2001-12-21

Substantially Equivalent

Vertis Neuroscience, Inc.

FDA 510(k) clearance K011702 for VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX, Substantially Equivalent on 2001-12-21. Applicant: Vertis Neuroscience, Inc.. Device class: 2.

Clearance details

Applicant: Vertis Neuroscience, Inc.
Product code: Code NHI
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2001-06-01
Decision date: 2001-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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