BIOLOGIC SYSTEM BL 101
FDA 510(k) clearance K831047 · decided 1983-05-13
Clearance details
- K-number
- K831047
- Device name
- BIOLOGIC SYSTEM BL 101
- Applicant
- Bio-Logic Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-31
- Decision date
- 1983-05-13
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- GWE
- Device class
- 2
- Regulation number
- 882.1890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.