The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Basic Heater-cooler Unit W/mast, 115/110v 16-21-10.
| Device ID | K883331 |
| 510k Number | K883331 |
| Device Name: | BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10 |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Ganz Pobuda |
| Correspondent | Ganz Pobuda SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-08 |
| Decision Date | 1988-09-26 |