BRC SOFTWARE PRODUCT
FDA 510(k) clearance K050192 · decided 2005-10-20
Clearance details
- K-number
- K050192
- Device name
- BRC SOFTWARE PRODUCT
- Applicant
- Brc Operations Pty Limited
- Decision
- Substantially Equivalent
- Date received
- 2005-01-27
- Decision date
- 2005-10-20
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- OLU
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Indianpolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.