Cleared Traditional

K905414 - MANGAR BOOSTER (FDA 510(k) Clearance)

K905414 · Northfleet Management Group, Inc. · General Hospital

Mar 1991

Decision

92d

Days

Class 2

Risk

K905414 is an FDA 510(k) clearance for the MANGAR BOOSTER. This device is classified as a Lift, Patient, Ac-powered (Class II - Special Controls, product code FNG).

Submitted by Northfleet Management Group, Inc. (Hopkinton, US). The FDA issued a Cleared decision on March 5, 1991, 92 days after receiving the submission on December 3, 1990.

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

Submission Details

510(k) Number	K905414 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 03, 1990
Decision Date	March 05, 1991
Days to Decision	92 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—