Cleared Traditional

AIR UTERINE DISPLACER-AUD 120

K833022 · Scientific Sales Intl., Inc. · Anesthesiology
Oct 1983
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K833022 is an FDA 510(k) clearance for the AIR UTERINE DISPLACER-AUD 120, a Support, Patient Position (Class I — General Controls, product code CCX), submitted by Scientific Sales Intl., Inc. (Walker, US). The FDA issued a Cleared decision on October 14, 1983, 38 days after receiving the submission on September 6, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6820.

Submission Details

510(k) Number K833022 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1983
Decision Date October 14, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CCX — Support, Patient Position
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.6820