SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100— 510(k) K960593

Name: FDA 510(k) clearance K960593
Creator: U.S. Food and Drug Administration
Published: 1996-05-10

Substantially Equivalent

Aradigm Corp.

FDA 510(k) clearance K960593 for SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100, Substantially Equivalent on 1996-05-10. Applicant: Aradigm Corp.. Device class: 1.

Clearance details

Applicant: Aradigm Corp.
Product code: Code CCQ
Device class: Class 1
Regulation: 21 CFR 868.5640
Advisory panel: Anesthesiology
Date received: 1996-02-12
Decision date: 1996-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CCQ

view all

K972397 — EZ SPRAY1997-09-23
K964956 — E-Z SPACER MASK (SMALL)1997-04-23
K961894 — MDI TUTOR1996-08-14
K961455 — MEDSHIELD/AEROCHAMBER1996-07-25
K922033 — SALINE SOLUTION- STERILE1992-07-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.