EVIS EXERA III VIDEO SYSTEM
FDA 510(k) clearance K121959 · decided 2013-01-10
Clearance details
- K-number
- K121959
- Device name
- EVIS EXERA III VIDEO SYSTEM
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-05
- Decision date
- 2013-01-10
- Days to decision
- 189 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
+ Add to Predicate Builder ◉ Watch Olympus Medical Systems Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.