The following data is part of a premarket notification filed by Cardio Systems, Inc. with the FDA for Add-on To Critical Patient Care Bed.
| Device ID | K882177 |
| 510k Number | K882177 |
| Device Name: | ADD-ON TO CRITICAL PATIENT CARE BED |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | CARDIO SYSTEMS, INC. P.O. BOX 29923 Dallas, TX 75229 |
| Contact | Charles E Hasty |
| Correspondent | Charles E Hasty CARDIO SYSTEMS, INC. P.O. BOX 29923 Dallas, TX 75229 |
| Product Code | IOQ |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-24 |
| Decision Date | 1988-12-01 |