PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor— 510(k) K181292
Substantially EquivalentCogentix Medical, Inc.
FDA 510(k) clearance K181292 for PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor, Substantially Equivalent on 2018-11-15. Applicant: Cogentix Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Cogentix Medical, Inc.
- Product code
- Code EOX
- Device class
- Class 2
- Regulation
- 21 CFR 874.4710
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orangeburg, NY, US
Recent devices under product code EOX
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