MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOS
FDA 510(k) clearance K900919 · decided 1990-05-14
Clearance details
- K-number
- K900919
- Device name
- MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOS
- Applicant
- Summit World Trade Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-02-20
- Decision date
- 1990-05-14
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hudson, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.