Cleared Traditional

ZAK-2000

K972022 · Cardio Systems, Inc. · General Hospital
Jan 1998
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K972022 is an FDA 510(k) clearance for the ZAK-2000, a Mattress, Air Flotation, Alternating Pressure (Class II — Special Controls, product code FNM), submitted by Cardio Systems, Inc. (Carrollton, US). The FDA issued a Cleared decision on January 22, 1998, 234 days after receiving the submission on June 2, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K972022 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1997
Decision Date January 22, 1998
Days to Decision 234 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FNM — Mattress, Air Flotation, Alternating Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5550