Cleared Traditional

HANS RUDOLPH NASAL CPAP MASK

K962848 · Hans Rudolph, Inc. · Anesthesiology
Oct 1996
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K962848 is an FDA 510(k) clearance for the HANS RUDOLPH NASAL CPAP MASK, a Mask, Oxygen (Class I — General Controls, product code BYG), submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on October 16, 1996, 86 days after receiving the submission on July 22, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number K962848 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1996
Decision Date October 16, 1996
Days to Decision 86 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BYG — Mask, Oxygen
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5580