Cleared Traditional

HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100

K122857 · Pegasus Research Corp. · Anesthesiology
Nov 2012
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K122857 is an FDA 510(k) clearance for the HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Pegasus Research Corp. (Costa Mesa, US). The FDA issued a Cleared decision on November 7, 2012, 50 days after receiving the submission on September 18, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K122857 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2012
Decision Date November 07, 2012
Days to Decision 50 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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