The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Clinitron Rite-hite.
| Device ID | K964223 |
| 510k Number | K964223 |
| Device Name: | CLINITRON RITE-HITE |
| Classification | Bed, Air Fluidized |
| Applicant | HILL-ROM, INC. 4349 CORPORATE RD. Charleston, SC 29405 |
| Contact | Edwin Hills |
| Correspondent | Edwin Hills HILL-ROM, INC. 4349 CORPORATE RD. Charleston, SC 29405 |
| Product Code | INX |
| CFR Regulation Number | 890.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-23 |
| Decision Date | 1997-05-28 |
| Summary: | summary |