THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR
FDA 510(k) clearance K850657 · decided 1985-02-22
Clearance details
- K-number
- K850657
- Device name
- THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR
- Applicant
- Flowtronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-01-28
- Decision date
- 1985-02-22
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- LME
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.