The following data is part of a premarket notification filed by Ch Administration, Inc. with the FDA for Cardio-systems Pro-op.
| Device ID | K953196 |
| 510k Number | K953196 |
| Device Name: | CARDIO-SYSTEMS PRO-OP |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | CH ADMINISTRATION, INC. 1201 NORTH INTERSTATE 35 Carrollton, TX 75006 |
| Contact | John Carbona |
| Correspondent | John Carbona CH ADMINISTRATION, INC. 1201 NORTH INTERSTATE 35 Carrollton, TX 75006 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-06 |
| Decision Date | 1995-11-08 |