Model SP5107 Thermodilution Catheter
FDA 510(k) K810730 · Gould, Inc.
510(k) numberK810730
Submission
- Device name
- Model SP5107 Thermodilution Catheter
- Applicant
- Gould, Inc.
Mchenry, IL, US - Received
- March 17, 1981
- Decision date
- March 27, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRB – Probe, Thermodilution
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1915
- Specialty
- Cardiovascular
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| 510(k) | Device | Decision |
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| K850113 | C/Pes 9103, ECG Stress Testing SystemDRT · Traditional | 02/08/1985SE |
| K843555 | Cardiac Computer SP1445DXG · Traditional | 02/01/1985SE |
| K843969 | Model P23XL Physiological Pressure TransducerDXO · Traditional | 01/23/1985SE |
Questions and answers
When was Model SP5107 Thermodilution Catheter cleared by the FDA?
Model SP5107 Thermodilution Catheter (K810730) received a 510(k) decision of Substantially Equivalent on March 27, 1981, 10 days after the submission was received.
What is the product code of K810730?
The FDA product code is KRB – Probe, Thermodilution, a Class II (moderate risk) device regulated under 21 CFR 870.1915.