Cleared Traditional

Spinal Manometer NRFit; Spinal Manometer LUER

K170305 · PAJUNK GmbH Medizintechnologie · General Hospital
Jul 2017
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K170305 is an FDA 510(k) clearance for the Spinal Manometer NRFit; Spinal Manometer LUER, a Manometer, Spinal-fluid (Class II — Special Controls, product code FMJ), submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on July 25, 2017, 175 days after receiving the submission on January 31, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2500.

Submission Details

510(k) Number K170305 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2017
Decision Date July 25, 2017
Days to Decision 175 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMJ — Manometer, Spinal-fluid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2500