Cleared Traditional

K926446 - EZ PUMP (FDA 510(k) Clearance)

K926446 · Alphamed, Inc. · General Hospital
Sep 1993
Decision
278d
Days
Class 1
Risk

K926446 is an FDA 510(k) clearance for the EZ PUMP. This device is classified as a Scale, Patient (Class I - General Controls, product code FRW).

Submitted by Alphamed, Inc. (Duluth, US). The FDA issued a Cleared decision on September 27, 1993, 278 days after receiving the submission on December 23, 1992.

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

Submission Details

510(k) Number K926446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date September 27, 1993
Days to Decision 278 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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