EVIS EXERA 180 SYSTEM
FDA 510(k) clearance K061313 · decided 2006-08-31
Clearance details
- K-number
- K061313
- Device name
- EVIS EXERA 180 SYSTEM
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-05-10
- Decision date
- 2006-08-31
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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