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

7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT is an FDA 510(k)-cleared medical device (K020759) manufactured by Hans Rudolph, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 12, 2002. Regulation: 8.