510(k) K844483
K844483 is an FDA 510(k) premarket notification submitted by Vitatron Medical BV for the device "TP 1". The FDA issued a decision of Substantially Equivalent on April 19, 1985. The device falls under product code KRG (Programmer, Pacemaker), a Class III device regulated under 21 CFR 870.3700. Vitatron Medical BV has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 1985
- Date Received
- November 19, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Programmer, Pacemaker
- Device Class
- Class III
- Regulation Number
- 870.3700
- Review Panel
- CV
- Submission Type