COMPUMEDICS SIESTA SYSTEM
FDA 510(k) clearance K003175 · decided 2000-12-27
Clearance details
- K-number
- K003175
- Device name
- COMPUMEDICS SIESTA SYSTEM
- Applicant
- Compumedics Limited
- Decision
- Substantially Equivalent
- Date received
- 2000-10-10
- Decision date
- 2000-12-27
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- OLV
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Minneapolis,, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.