Product code LME
- Device name
- Monitor, Blood-Flow, Cerebral, Thermal Diffusion
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K850657 | THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR | Flowtronics, Inc. | 1985-02-22 |