Clearance Summary
7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT received FDA 510(k) clearance under submission number K020759, sponsored by Hans Rudolph, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2002-08-13.
- Submission: K020759
- Applicant / Sponsor: Hans Rudolph, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2002-08-13
Classification & Regulation
This clearance is catalogued under FDA product code BZD and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.