Cleared Traditional

HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS

K030515 · Hans Rudolph, Inc. · Anesthesiology
May 2003
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K030515 is an FDA 510(k) clearance for the HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on May 2, 2003, 72 days after receiving the submission on February 19, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K030515 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2003
Decision Date May 02, 2003
Days to Decision 72 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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