Cleared Special

RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V

K101857 · Instrumentation Industries, Inc. · Anesthesiology
Jul 2010
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K101857 is an FDA 510(k) clearance for the RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on July 22, 2010, 20 days after receiving the submission on July 2, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K101857 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2010
Decision Date July 22, 2010
Days to Decision 20 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

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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