Cleared Traditional

K951770 - BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
(FDA 510(k) Clearance)

K951770 · Biodex Medical Systems, Inc. · Physical Medicine device

Nov 1995

Decision

213d

Days

Class 2

Risk

K951770 is an FDA 510(k) clearance for the BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP. This device is classified as a System, Isokinetic Testing And Evaluation (Class II - Special Controls, product code IKK).

Submitted by Biodex Medical Systems, Inc. (Shirley, US). The FDA issued a Cleared decision on November 16, 1995, 213 days after receiving the submission on April 17, 1995.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.1925.

Submission Details

510(k) Number	K951770 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 17, 1995
Decision Date	November 16, 1995
Days to Decision	213 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF