510(k) K863508
K863508 is an FDA 510(k) premarket notification submitted by Frantz Medical Development, Ltd. for the device "FRANTZ MEDICAL ELECTRODE". The FDA issued a decision of Substantially Equivalent on February 6, 1987. The device falls under product code DXR (Ballistocardiograph), a Class II device regulated under 21 CFR 870.2320. Frantz Medical Development, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 1987
- Date Received
- September 9, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ballistocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2320
- Review Panel
- CV
- Submission Type