The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Stockert-shiley Bubble Monitor 23-23-01.
| Device ID | K881006 |
| 510k Number | K881006 |
| Device Name: | STOCKERT-SHILEY BUBBLE MONITOR 23-23-01 |
| Classification | Monitor, Blood-gas, On-line, 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 | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-09 |
| Decision Date | 1988-05-24 |