PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
FDA 510(k) clearance K181292 · decided 2018-11-15
Clearance details
- K-number
- K181292
- Device name
- PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
- Applicant
- Cogentix Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-05-16
- Decision date
- 2018-11-15
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- EOX
- Device class
- 2
- Regulation number
- 874.4710
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Orangeburg, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.