The following data is part of a premarket notification filed by Hans Rudolph, Inc. with the FDA for 7600 Series Reusable Full-face Cpap/nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit.
| Device ID | K020759 |
| 510k Number | K020759 |
| Device Name: | 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | HANS RUDOLPH, INC. 7205 CENTRAL Kansas City, MO 64114 |
| Contact | Kevin Rudolph |
| Correspondent | Kevin Rudolph HANS RUDOLPH, INC. 7205 CENTRAL Kansas City, MO 64114 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-07 |
| Decision Date | 2002-08-13 |
| Summary: | summary |