Cleared Traditional

K923350 - CLOSED CHAIN ATTACHMENT, MODEL #820-520
(FDA 510(k) Clearance)

K923350 · Biodan Medical Systems, Ltd. · Physical Medicine device

Jul 1992

Decision

15d

Days

Class 2

Risk

K923350 is an FDA 510(k) clearance for the CLOSED CHAIN ATTACHMENT, MODEL #820-520. This device is classified as a System, Isokinetic Testing And Evaluation (Class II - Special Controls, product code IKK).

Submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on July 23, 1992, 15 days after receiving the submission on July 8, 1992.

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

Submission Details

510(k) Number	K923350 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 08, 1992
Decision Date	July 23, 1992
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement