The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Model Sp5107 Thermodilution Catheter.
| Device ID | K810730 |
| 510k Number | K810730 |
| Device Name: | MODEL SP5107 THERMODILUTION CATHETER |
| Classification | Probe, Thermodilution |
| Applicant | GOULD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Contact | None None |
| Correspondent | None None GOULD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-17 |
| Decision Date | 1981-03-27 |