OLYMPUS BF TYPE UC160-OL8
FDA 510(k) clearance K042140 · decided 2004-08-18
Clearance details
- K-number
- K042140
- Device name
- OLYMPUS BF TYPE UC160-OL8
- Applicant
- Olympus Corporation
- Decision
- Substantially Equivalent
- Date received
- 2004-08-09
- Decision date
- 2004-08-18
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- ODG
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Melville, NY, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.