Cleared Traditional

RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC

K091111 · Instrumentation Industries, Inc. · Anesthesiology
Dec 2009
Decision
229d
Days
Class 2
Risk

About This 510(k) Submission

K091111 is an FDA 510(k) clearance for the RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC, 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 December 2, 2009, 229 days after receiving the submission on April 17, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K091111 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2009
Decision Date December 02, 2009
Days to Decision 229 days
Submission Type Traditional
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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