Cleared Traditional

K791566 - MODEL AS* 6C INFUSION PUMP (FDA 510(k) Clearance)

Nov 1979
Decision
95d
Days
Class 1
Risk

K791566 is an FDA 510(k) clearance for the MODEL AS* 6C INFUSION PUMP. This device is classified as a Scale, Patient (Class I - General Controls, product code FRW).

Submitted by Baxter Healthcare Corp (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979, 95 days after receiving the submission on August 10, 1979.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2720.

Submission Details

510(k) Number K791566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1979
Decision Date November 13, 1979
Days to Decision 95 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code FRW — Scale, Patient
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.2720