510(k) K802588
K802588 is an FDA 510(k) premarket notification submitted by Arco Medical Products Co. for the device "MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN.". The FDA issued a decision of Substantially Equivalent on November 19, 1980. 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
- November 19, 1980
- Date Received
- October 20, 1980
- 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