The following data is part of a premarket notification filed by Daily Medical Products, Inc. with the FDA for Cardiac Cooling Jacket, 8 Cm, Model Cj-120.
| Device ID | K896974 |
| 510k Number | K896974 |
| Device Name: | CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | DAILY MEDICAL PRODUCTS, INC. 3665 KEARNY VILLA RD. STE 301 San Diego, CA 92123 |
| Contact | Alan Secord |
| Correspondent | Alan Secord DAILY MEDICAL PRODUCTS, INC. 3665 KEARNY VILLA RD. STE 301 San Diego, CA 92123 |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-13 |
| Decision Date | 1990-02-05 |