Cleared Traditional

K842120 - ZERO-G
(FDA 510(k) Clearance)

K842120 · Steridyne Corp. · Physical Medicine device

Jun 1984

Decision

10d

Days

Class 1

Risk

K842120 is an FDA 510(k) clearance for the ZERO-G. This device is classified as a Cushion, Flotation (Class I - General Controls, product code KIC).

Submitted by Steridyne Corp. (Walker, US). The FDA issued a Cleared decision on June 8, 1984, 10 days after receiving the submission on May 29, 1984.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3175.

Submission Details

510(k) Number	K842120 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 29, 1984
Decision Date	June 08, 1984
Days to Decision	10 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—