The following data is part of a premarket notification filed by Cardio Systems, Inc. with the FDA for Low Air Loss Mattress, Modification.
| Device ID | K934689 |
| 510k Number | K934689 |
| Device Name: | LOW AIR LOSS MATTRESS, MODIFICATION |
| Classification | Bed, Air Fluidized |
| Applicant | CARDIO SYSTEMS, INC. P.O. BOX 29923 Dallas, TX 75229 |
| Contact | John A Carbona |
| Correspondent | John A Carbona CARDIO SYSTEMS, INC. P.O. BOX 29923 Dallas, TX 75229 |
| Product Code | INX |
| CFR Regulation Number | 890.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-23 |
| Decision Date | 1994-02-02 |