Cleared Traditional

KHM 2000 DRIP WATCHER

K844556 · The Timeter Group · General Hospital
Jan 1985
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K844556 is an FDA 510(k) clearance for the KHM 2000 DRIP WATCHER, a Monitor, Electric For Gravity Flow Infusion Systems (Class II — Special Controls, product code FLN), submitted by The Timeter Group (Lancaster, US). The FDA issued a Cleared decision on January 14, 1985, 54 days after receiving the submission on November 21, 1984. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2420.

Submission Details

510(k) Number K844556 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 1984
Decision Date January 14, 1985
Days to Decision 54 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FLN — Monitor, Electric For Gravity Flow Infusion Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2420