Cleared Traditional

K942184 - CLINITRON AT HOME AIR FLUIDED THERAPY
(FDA 510(k) Clearance)

K942184 · Ssi Medical Services, Inc. · Physical Medicine device

Feb 1995

Decision

279d

Days

Class 2

Risk

K942184 is an FDA 510(k) clearance for the CLINITRON AT HOME AIR FLUIDED THERAPY. This device is classified as a Bed, Air Fluidized (Class II - Special Controls, product code INX).

Submitted by Ssi Medical Services, Inc. (Charleston, US). The FDA issued a Cleared decision on February 7, 1995, 279 days after receiving the submission on May 4, 1994.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5160.

Submission Details

510(k) Number	K942184 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 04, 1994
Decision Date	February 07, 1995
Days to Decision	279 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement