The following data is part of a premarket notification filed by Daily Medical Products, Inc. with the FDA for Topical Cooling Pad, Model 7000.
| Device ID | K905568 |
| 510k Number | K905568 |
| Device Name: | TOPICAL COOLING PAD, MODEL 7000 |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | DAILY MEDICAL PRODUCTS, INC. 3665 KEARNY VILLA RD. STE 301 San Diego, CA 92123 |
| Contact | Alan Seacord |
| Correspondent | Alan Seacord DAILY MEDICAL PRODUCTS, INC. 3665 KEARNY VILLA RD. STE 301 San Diego, CA 92123 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-12 |
| Decision Date | 1991-01-23 |