The following data is part of a premarket notification filed by Ethos Medical Products Ltd. with the FDA for Roto Rest; Trauma And Intensive Care Bed.
| Device ID | K905113 |
| 510k Number | K905113 |
| Device Name: | ROTO REST; TRAUMA AND INTENSIVE CARE BED |
| Classification | Bed, Patient Rotation, Powered |
| Applicant | ETHOS MEDICAL PRODUCTS LTD. MONKSLAND INDUSTRIAL ESTATE Athlone, IE |
| Contact | Pat Connolly |
| Correspondent | Pat Connolly ETHOS MEDICAL PRODUCTS LTD. MONKSLAND INDUSTRIAL ESTATE Athlone, IE |
| Product Code | IKZ |
| CFR Regulation Number | 890.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-13 |
| Decision Date | 1990-11-26 |