Cleared Traditional

FLUID MANAGEMENT SYSTEM

K852645 · Haemonetics Corp. · General Hospital
Dec 1985
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K852645 is an FDA 510(k) clearance for the FLUID MANAGEMENT SYSTEM, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on December 9, 1985, 171 days after receiving the submission on June 21, 1985. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K852645 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 1985
Decision Date December 09, 1985
Days to Decision 171 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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