510(k) K915864
K915864 is an FDA 510(k) premarket notification submitted by Henley Intl. for the device "MONOTRODE CUTANEOUS ELECTRODE". The FDA issued a decision of Substantially Equivalent on July 21, 1993. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Henley Intl. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1993
- Date Received
- December 31, 1991
- 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