510(k) K940012
K940012 is an FDA 510(k) premarket notification submitted by Medical Devices, Inc. for the device "SMARTBRACE ELECTRODE". The FDA issued a decision of Substantially Equivalent on December 5, 1994. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Medical Devices, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 1994
- Date Received
- January 4, 1994
- 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