510(k) K831859
K831859 is an FDA 510(k) premarket notification submitted by Vitatron Medical BV for the device "PACEMAKER PROGRAMMER #2032". The FDA issued a decision of Substantially Equivalent on October 27, 1983. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Vitatron Medical BV has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 1983
- Date Received
- June 10, 1983
- 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