NEURON MAX SYSTEM
FDA 510(k) clearance K111380 · decided 2011-07-19
Clearance details
- K-number
- K111380
- Device name
- NEURON MAX SYSTEM
- Applicant
- Penumbra, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-16
- Decision date
- 2011-07-19
- Days to decision
- 64 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Alameda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.