Cleared Traditional

ALTERA NEBULIZER SYSTEM, MODEL 678G1002

K100380 · Pari Respiratory Equipment, Inc. · Anesthesiology
Feb 2010
Decision
6d
Days
Class 2
Risk

About This 510(k) Submission

K100380 is an FDA 510(k) clearance for the ALTERA NEBULIZER SYSTEM, MODEL 678G1002, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Pari Respiratory Equipment, Inc. (Midlothian, US). The FDA issued a Cleared decision on February 22, 2010, 6 days after receiving the submission on February 16, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K100380 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2010
Decision Date February 22, 2010
Days to Decision 6 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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