Cleared Traditional

CAREPAK

K942350 · Precision Medical, Inc. · Anesthesiology
Dec 1994
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K942350 is an FDA 510(k) clearance for the CAREPAK, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on December 6, 1994, 203 days after receiving the submission on May 17, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K942350 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 1994
Decision Date December 06, 1994
Days to Decision 203 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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