510(k) K081279
K081279 is an FDA 510(k) premarket notification submitted by Transfer Technology for the device "PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000". The FDA issued a decision of Substantially Equivalent on Jan 23, 2009. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 23, 2009
- Date Received
- May 6, 2008
- 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
- 510(k)