BIOSACA SYSTEM, MODEL 800
FDA 510(k) clearance K991446 · decided 1999-07-23
Clearance details
- K-number
- K991446
- Device name
- BIOSACA SYSTEM, MODEL 800
- Applicant
- Biosys AB (Publ)
- Decision
- Substantially Equivalent
- Date received
- 1999-04-26
- Decision date
- 1999-07-23
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- OLV
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Chester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.