510(k) K152948
K152948 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "Medline Anti-Fog Solution". The FDA issued a decision of Substantially Equivalent on February 4, 2016. The device falls under product code OCT (Anti Fog Solution And Accessories, Endoscopy), a Class II device regulated under 21 CFR 876.1500. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2016
- Date Received
- October 6, 2015
- 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.