Cleared Traditional

PRECI-JET 50

K851181 · Ulster Scientific, Inc. · General Hospital
Jun 1985
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K851181 is an FDA 510(k) clearance for the PRECI-JET 50, a Injector, Fluid, Non-electrically Powered (Class II — Special Controls, product code KZE), submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on June 6, 1985, 73 days after receiving the submission on March 25, 1985. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5430.

Submission Details

510(k) Number K851181 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1985
Decision Date June 06, 1985
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code KZE — Injector, Fluid, Non-electrically Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5430

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