The following data is part of a premarket notification filed by Cardio Systems, Inc. with the FDA for Zak-2000.
| Device ID | K972022 |
| 510k Number | K972022 |
| Device Name: | ZAK-2000 |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | CARDIO SYSTEMS, INC. 1201 NORTH INTERSTATE 35 Carrollton, TX 75006 |
| Contact | Mike A Scanlan |
| Correspondent | Mike A Scanlan CARDIO SYSTEMS, 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 | 1997-06-02 |
| Decision Date | 1998-01-22 |