POINTER PLUS— 510(k) K060508

Substantially Equivalent

Lhasa Oms, Inc.

FDA 510(k) clearance K060508 for POINTER PLUS, Substantially Equivalent on 2006-06-19. Applicant: Lhasa Oms, Inc.. Device class: 2.

Clearance details

Applicant: Lhasa Oms, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2006-02-27
Decision date: 2006-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weymouth, MA, US

Download summary PDF View on FDA.gov ↗

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