Spinal Manometer NRFit; Spinal Manometer LUER— 510(k) K170305

Name: FDA 510(k) clearance K170305
Creator: U.S. Food and Drug Administration
Published: 2017-07-25

Substantially Equivalent

PAJUNK GmbH Medizintechnologie

FDA 510(k) clearance K170305 for Spinal Manometer NRFit; Spinal Manometer LUER, Substantially Equivalent on 2017-07-25. Applicant: PAJUNK GmbH Medizintechnologie. Device class: 2.

Clearance details

Applicant: PAJUNK GmbH Medizintechnologie
Product code: Code FMJ
Device class: Class 2
Regulation: 21 CFR 880.2500
Advisory panel: General Hospital
Date received: 2017-01-31
Decision date: 2017-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geisingen, DE

Download summary PDF View on FDA.gov ↗

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