Cleared Traditional

K882161 - ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM
(FDA 510(k) Clearance)

K882161 · Ssi Medical Services, Inc. · General Hospital

Jul 1988

Decision

50d

Days

Class 2

Risk

K882161 is an FDA 510(k) clearance for the ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM. This device is classified as a Mattress, Air Flotation, Alternating Pressure (Class II - Special Controls, product code FNM).

Submitted by Ssi Medical Services, Inc. (Chicago, US). The FDA issued a Cleared decision on July 12, 1988, 50 days after receiving the submission on May 23, 1988.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number	K882161 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 23, 1988
Decision Date	July 12, 1988
Days to Decision	50 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—