The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Neocath 1000 Umbilical Artery Oxygen Monitoring Sy.
| Device ID | K895149 |
| 510k Number | K895149 |
| Device Name: | NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY |
| Classification | Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Allan Abati |
| Correspondent | Allan Abati SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | CCE |
| CFR Regulation Number | 868.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-23 |
| Decision Date | 1989-11-28 |