510(k) K761237
K761237 is an FDA 510(k) premarket notification submitted by Arco Medical Products Co. for the device "ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-5". The FDA issued a decision of Substantially Equivalent on December 21, 1976. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Arco Medical Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 1976
- Date Received
- December 13, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implantable Pacemaker Pulse-Generator
- Device Class
- Class III
- Regulation Number
- 870.3610
- Review Panel
- CV
- Submission Type