510(k) K111622
K111622 is an FDA 510(k) premarket notification submitted by Unimax Medical Systems, Inc. for the device "UNIMAX ANTI-FOG SOLUTION". The FDA issued a decision of Substantially Equivalent on September 9, 2011. The device falls under product code OCT (Anti Fog Solution And Accessories, Endoscopy), a Class II device regulated under 21 CFR 876.1500. Unimax Medical Systems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2011
- Date Received
- June 10, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti Fog Solution And Accessories, Endoscopy
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To prevent, reduce or eliminate condensation (fog) on endoscopic lens.