The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Cco System Model Sp1467,sp5567,sp6267.
| Device ID | K892941 |
| 510k Number | K892941 |
| Device Name: | CCO SYSTEM MODEL SP1467,SP5567,SP6267 |
| Classification | Probe, Thermodilution |
| Applicant | SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Contact | Robert Leavitt |
| Correspondent | Robert Leavitt SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-21 |
| Decision Date | 1989-11-06 |