FUJITENS III
FDA 510(k) clearance K893874 · decided 1989-12-22
Clearance details
- K-number
- K893874
- Device name
- FUJITENS III
- Applicant
- Altoona Medical Supply
- Decision
- Substantially Equivalent
- Date received
- 1989-05-26
- Decision date
- 1989-12-22
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- GZQ
- Device class
- 2
- Regulation number
- 882.4275
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Altoona, IA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.