The following data is part of a premarket notification filed by Daily Medical, Inc. with the FDA for Cardiac Cooling Jacked, 16 Cm, Model Cj-620.
| Device ID | K896393 |
| 510k Number | K896393 |
| Device Name: | CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | DAILY MEDICAL, INC. 9225 CHESAPEAKE DR. STE. D San Diego, CA 92123 |
| Contact | Alan Seacord |
| Correspondent | Alan Seacord DAILY MEDICAL, INC. 9225 CHESAPEAKE DR. STE. D 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 | 1989-11-06 |
| Decision Date | 1990-02-02 |