Cleared Traditional

K790860 - RT-HOOD
(FDA 510(k) Clearance)

May 1979
Decision
22d
Days
Class 1
Risk

K790860 is an FDA 510(k) clearance for the RT-HOOD. This device is classified as a Hood, Oxygen, Infant (Class I - General Controls, product code FOG).

Submitted by Plastics Supplies & Products (Mchenry, US). The FDA issued a Cleared decision on May 29, 1979, 22 days after receiving the submission on May 7, 1979.

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

Submission Details

510(k) Number K790860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1979
Decision Date May 29, 1979
Days to Decision 22 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