510(k) K964433
K964433 is an FDA 510(k) premarket notification submitted by Medibond , Ltd. for the device "AQUABOND ELECTRODE". The FDA issued a decision of Substantially Equivalent on Jan 27, 1997. 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 27, 1997
- Date Received
- Nov 5, 1996
- 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)