510(k) K873716
K873716 is an FDA 510(k) premarket notification submitted by Martin Medical for the device "ADULT WALKING HEEL PRODUCT NO. 4183-130". The FDA issued a decision of Substantially Equivalent on October 2, 1987. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Martin Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1987
- Date Received
- September 15, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Pacemaker, Temporary
- Device Class
- Class II
- Regulation Number
- 870.3680
- Review Panel
- CV
- Submission Type