Cleared Traditional

SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100

K960593 · Aradigm Corp. · Anesthesiology
May 1996
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K960593 is an FDA 510(k) clearance for the SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100, a Nebulizer, Medicinal, Non-ventilatory (atomizer) (Class I — General Controls, product code CCQ), submitted by Aradigm Corp. (Hayward, US). The FDA issued a Cleared decision on May 10, 1996, 88 days after receiving the submission on February 12, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5640.

Submission Details

510(k) Number K960593 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1996
Decision Date May 10, 1996
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCQ — Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5640