The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Silkair Low Airloss Therapy.
| Device ID | K964873 |
| 510k Number | K964873 |
| Device Name: | SILKAIR LOW AIRLOSS THERAPY |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | HILL-ROM, INC. 4349 CORPORATE RD. Charleston, SC 29405 |
| Contact | Edwin Bills |
| Correspondent | Edwin Bills HILL-ROM, INC. 4349 CORPORATE RD. Charleston, SC 29405 |
| Product Code | IOQ |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-05 |
| Decision Date | 1997-07-03 |
| Summary: | summary |