Cleared Traditional

K780779 - ECONO-FLOAT WATER FLOTATION MATTRESS
(FDA 510(k) Clearance)

May 1978
Decision
8d
Days
Class 1
Risk

K780779 is an FDA 510(k) clearance for the ECONO-FLOAT WATER FLOTATION MATTRESS. This device is classified as a Mattress, Flotation Therapy, Non-powered (Class I - General Controls, product code IKY).

Submitted by Jefferson Industries, Inc. (Walker, US). The FDA issued a Cleared decision on May 19, 1978, 8 days after receiving the submission on May 11, 1978.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5150.

Submission Details

510(k) Number K780779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1978
Decision Date May 19, 1978
Days to Decision 8 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code IKY — Mattress, Flotation Therapy, Non-powered
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.5150