The following data is part of a premarket notification filed by Penox Technologies, Inc. with the FDA for Penox Hospital Bed.
| Device ID | K864667 |
| 510k Number | K864667 |
| Device Name: | PENOX HOSPITAL BED |
| Classification | Bed, Manual |
| 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 | FNJ |
| CFR Regulation Number | 880.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-02 |
| Decision Date | 1987-01-21 |