510(k) K791006
K791006 is an FDA 510(k) premarket notification submitted by Electronics For Medicine, Inc. for the device "SMART BILECTRODES". The FDA issued a decision of Substantially Equivalent on Jun 11, 1979. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Electronics For Medicine, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 11, 1979
- Date Received
- May 31, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Electrode, Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2360
- Review Panel
- CV
- Submission Type
- 510(k) Exempt