The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Pulmonex Dynamic Air Therapy Unit.
| Device ID | K950756 |
| 510k Number | K950756 |
| Device Name: | PULMONEX DYNAMIC AIR THERAPY UNIT |
| Classification | Bed, Patient Rotation, 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 | IKZ |
| CFR Regulation Number | 890.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-17 |
| Decision Date | 1995-05-30 |