The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Stockert-shiley Caps 4 Channel Temp. Monitor 1.
| Device ID | K862510 |
| 510k Number | K862510 |
| Device Name: | STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1 |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Radine Pobuda |
| Correspondent | Radine Pobuda SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-01 |
| Decision Date | 1986-07-17 |