The following data is part of a premarket notification filed by Orange Medical Instruments, Inc. with the FDA for Neocath 1000 W/hepcote.
| Device ID | K832793 |
| 510k Number | K832793 |
| Device Name: | NEOCATH 1000 W/HEPCOTE |
| Classification | Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Applicant | ORANGE MEDICAL INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CCE |
| CFR Regulation Number | 868.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-19 |
| Decision Date | 1983-09-26 |