Cleared Traditional

DISPOS. MEDICATION NEBULIZER

K831270 · Hospitak, Inc. · Anesthesiology
Jun 1983
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K831270 is an FDA 510(k) clearance for the DISPOS. MEDICATION NEBULIZER, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Hospitak, Inc. (Walker, US). The FDA issued a Cleared decision on June 8, 1983, 50 days after receiving the submission on April 19, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K831270 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1983
Decision Date June 08, 1983
Days to Decision 50 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

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