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 |