CLARUS NEURO ENDOSCOPE (MODEL 2230)
FDA 510(k) clearance K941188 · decided 1995-04-25
Clearance details
- K-number
- K941188
- Device name
- CLARUS NEURO ENDOSCOPE (MODEL 2230)
- Applicant
- Clarus Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-03-14
- Decision date
- 1995-04-25
- Days to decision
- 407 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- 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.