Cleared Traditional

K792144 - DISPOSA-HOOD
(FDA 510(k) Clearance)

Dec 1979
Decision
43d
Days
Class 1
Risk

K792144 is an FDA 510(k) clearance for the DISPOSA-HOOD. This device is classified as a Hood, Oxygen, Infant (Class I - General Controls, product code FOG).

Submitted by Utah Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 5, 1979, 43 days after receiving the submission on October 23, 1979.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5700.

Submission Details

510(k) Number K792144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1979
Decision Date December 05, 1979
Days to Decision 43 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code FOG — Hood, Oxygen, Infant
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.5700