Cleared Traditional

HOPE NEBULIZER

K980407 · B&B Medical Technologies, Inc. · Anesthesiology
May 1998
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K980407 is an FDA 510(k) clearance for the HOPE NEBULIZER, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by B&B Medical Technologies, Inc. (Rancho Cordova, US). The FDA issued a Cleared decision on May 27, 1998, 113 days after receiving the submission on February 3, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K980407 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1998
Decision Date May 27, 1998
Days to Decision 113 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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