510(k) K131338
K131338 is an FDA 510(k) premarket notification submitted by Globalmedia Group, LLC for the device "DERMA HOOD". The FDA issued a decision of Substantially Equivalent on July 10, 2013. The device falls under product code PEQ (Accessories To Examination Light), a Class I device regulated under 21 CFR 880.6320.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2013
- Date Received
- May 9, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories To Examination Light
- Device Class
- Class I
- Regulation Number
- 880.6320
- Review Panel
- HO
- Submission Type
Accessories that attach to the light and assist in magnifying, clarifying, enhancing the image being viewed.