Cleared Traditional

K935351 - A.C. POWER PATIENT LIFT (FDA 510(k) Clearance)

K935351 · Ken Kemmerer · General Hospital

Feb 1994

Decision

115d

Days

Class 2

Risk

K935351 is an FDA 510(k) clearance for the A.C. POWER PATIENT LIFT. This device is classified as a Lift, Patient, Ac-powered (Class II - Special Controls, product code FNG).

Submitted by Ken Kemmerer (Wilkes Barre Twp, US). The FDA issued a Cleared decision on February 28, 1994, 115 days after receiving the submission on November 5, 1993.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5500.

Submission Details

510(k) Number	K935351 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 05, 1993
Decision Date	February 28, 1994
Days to Decision	115 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF