510(k) K072799
K072799 is an FDA 510(k) premarket notification submitted by Vision Quest Industries, Inc. for the device "TARGET STERILE ELECTRODE". The FDA issued a decision of Substantially Equivalent on April 24, 2008. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Vision Quest Industries, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2008
- Date Received
- October 1, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type