SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION
FDA 510(k) clearance K875378 · decided 1988-11-16
Clearance details
- K-number
- K875378
- Device name
- SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION
- Applicant
- Shimadzu Precision Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-31
- Decision date
- 1988-11-16
- Days to decision
- 321 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Torrance, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.