510(k) K850657
- Device
- THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR
- Applicant
- FLOWTRONICS, INC.
- 510(k) number
- K850657
- Product code
- LME
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-02-22
- Date received
- 1985-01-28
- Regulation
- 510(k) Premarket Notification
- Classification name
- Monitor, Blood-flow, Cerebral, Thermal Diffusion
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Neurology
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- MARGARET A SULLIVAN
- Address
- 10250 N. 19th Ave., Suite B Phoenix AZ US 85021 85021
Source Documents
510(k) summary PDF not indicated by FDA
Legacy Summary
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FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases