Cleared Traditional

METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D

K981249 · Instrumentation Industries, Inc. · Anesthesiology
Nov 1998
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K981249 is an FDA 510(k) clearance for the METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D, 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 November 23, 1998, 231 days after receiving the submission on April 6, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K981249 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 1998
Decision Date November 23, 1998
Days to Decision 231 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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