510(k) K020759

7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT by Hans Rudolph, Inc. — Product Code BZD

K020759 is an FDA 510(k) premarket notification submitted by Hans Rudolph, Inc. for the device "7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT". The FDA issued a decision of Substantially Equivalent on August 13, 2002. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Hans Rudolph, Inc. has at least 10 other 510(k) clearances on record.