Cleared Traditional

PHYSIO/1000

K974070 · Physio Designs, Inc. · General Hospital
Jan 1998
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K974070 is an FDA 510(k) clearance for the PHYSIO/1000, a Mattress, Air Flotation, Alternating Pressure (Class II — Special Controls, product code FNM), submitted by Physio Designs, Inc. (Commack, US). The FDA issued a Cleared decision on January 6, 1998, 70 days after receiving the submission on October 28, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K974070 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1997
Decision Date January 06, 1998
Days to Decision 70 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