SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT
FDA 510(k) clearance K827346 · decided 1983-02-14
Clearance details
- K-number
- K827346
- Device name
- SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT
- Applicant
- Rayflow Italia S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-22
- Decision date
- 1983-02-14
- Days to decision
- 54 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.