The following data is part of a premarket notification filed by Penox Technologies, Inc. with the FDA for Penox High Flow Manifold.
| Device ID | K853775 |
| 510k Number | K853775 |
| Device Name: | PENOX HIGH FLOW MANIFOLD |
| Classification | Unit, Liquid-oxygen, Portable |
| Applicant | PENOX TECHNOLOGIES, INC. ONE PENOX PLAZA, COMMERCE RD. P.O. BOX 785 Pittston, PA 18640 |
| Contact | Thana A France |
| Correspondent | Thana A France PENOX TECHNOLOGIES, INC. ONE PENOX PLAZA, COMMERCE RD. P.O. BOX 785 Pittston, PA 18640 |
| Product Code | BYJ |
| CFR Regulation Number | 868.5655 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-10 |
| Decision Date | 1985-11-29 |