THERASTEAM PERSONAL STEAM INHALER— 510(k) K950116

Substantially Equivalent

Kaz, Inc.

FDA 510(k) clearance K950116 for THERASTEAM PERSONAL STEAM INHALER, Substantially Equivalent on 1995-02-10. Applicant: Kaz, Inc.. Device class: 1.

Clearance details

Applicant: Kaz, Inc.
Product code: Code KFZ
Device class: Class 1
Regulation: 21 CFR 868.5460
Advisory panel: Anesthesiology
Date received: 1995-01-11
Decision date: 1995-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Kaz, Inc.

K103839 — BEHIND EAR GENTLE TOUCH THERMOMETER2011-06-06

Recalls naming K950116

K-number listed on FDA's recall record

Z-1935-2021 — VAPORIZER VICKS 1.5GAL Item Number: 2354942Class II·Ongoing·Cardinal Health Inc.·20210316

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K950116.

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