Cleared Traditional

FLUID MANAGEMENT SYSTEM (MODIFIED)

K860969 · Haemonetics Corp. · General Hospital
May 1986
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K860969 is an FDA 510(k) clearance for the FLUID MANAGEMENT SYSTEM (MODIFIED), a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on May 6, 1986, 56 days after receiving the submission on March 11, 1986. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K860969 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1986
Decision Date May 06, 1986
Days to Decision 56 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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