Cleared Traditional

K934689 - LOW AIR LOSS MATTRESS, MODIFICATION
(FDA 510(k) Clearance)

K934689 · Cardio Systems, Inc. · Physical Medicine
Feb 1994
Decision
163d
Days
Class 2
Risk

K934689 is an FDA 510(k) clearance for the LOW AIR LOSS MATTRESS, MODIFICATION. This device is classified as a Bed, Air Fluidized (Class II — Special Controls, product code INX).

Submitted by Cardio Systems, Inc. (Dallas, US). The FDA issued a Cleared decision on February 2, 1994, 163 days after receiving the submission on August 23, 1993.

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

Submission Details

510(k) Number K934689 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 1993
Decision Date February 02, 1994
Days to Decision 163 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code INX — Bed, Air Fluidized
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5160