Cleared Traditional

7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT

K020759 · Hans Rudolph, Inc. · Anesthesiology

Aug 2002

Decision

159d

Days

Class 2

Risk

About This 510(k) Submission

K020759 is an FDA 510(k) clearance for the 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on August 13, 2002, 159 days after receiving the submission on March 7, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K020759 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 2002
Decision Date	August 13, 2002
Days to Decision	159 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF