Cleared Traditional

CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM

K973917 · Sims Deltec, Inc. · General Hospital
Jan 1998
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K973917 is an FDA 510(k) clearance for the CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 9, 1998, 86 days after receiving the submission on October 15, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K973917 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1997
Decision Date January 09, 1998
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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