The following data is part of a premarket notification filed by Orange Medical Instruments, Inc. with the FDA for Continucath.
| Device ID | K860808 |
| 510k Number | K860808 |
| Device Name: | CONTINUCATH |
| Classification | Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Applicant | ORANGE MEDICAL INSTRUMENTS, INC. P.O. BOX 88, GEORGE ST. HIGH WYCOMBE Buckinghamshire, England, GB Hp112rz |
| Contact | B. C Crane |
| Correspondent | B. C Crane ORANGE MEDICAL INSTRUMENTS, INC. P.O. BOX 88, GEORGE ST. HIGH WYCOMBE Buckinghamshire, England, GB Hp112rz |
| Product Code | CCE |
| CFR Regulation Number | 868.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-03-13 |