The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Dynamicaire(tm) Sleep Surface, Zoneair(tm) Sleep Surface.
| Device ID | K945729 |
| 510k Number | K945729 |
| Device Name: | DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | HILL-ROM, INC. 1069 STATE ROUTE 46 EAST Batesville, IN 47006 |
| Contact | James G Carpenter |
| Correspondent | James G Carpenter HILL-ROM, INC. 1069 STATE ROUTE 46 EAST Batesville, IN 47006 |
| Product Code | IOQ |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-22 |
| Decision Date | 1995-02-27 |