KRG — Programmer, Pacemaker Class III
FDA product code KRG covers "Programmer, Pacemaker", a Class III medical device regulated under 21 CFR 870.3700. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KRG
- Device Class
- Class III
- Regulation Number
- 870.3700
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K933278 | intermedics | INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 | March 15, 1995 |
| K884522 | teletronics | MODEL 5650 OPTIMATE PERSONAL PROGRAMMER | August 25, 1989 |
| K880738 | medtronic vascular | MODEL 2331T PATIENT PROGRAMMER | November 17, 1988 |
| K882429 | tpl-cordis | MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 | July 22, 1988 |
| K864712 | telectronics | MODEL 1740 PERSONAL POCKET PROGRAMMER | December 17, 1987 |
| K871986 | telectronics | MODEL 5600B PROGRAMMER, PACEMAKER | June 24, 1987 |
| K863046 | cardiac pacemakers | ULTRA SOFTWARE MODULE: MODEL 2016 | December 5, 1986 |
| K863045 | cardiac pacemakers | PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 | September 29, 1986 |
| K860584 | cardiac pacemakers | SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN | June 6, 1986 |
| K860546 | pacesetter systems | DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 | April 23, 1986 |
| K844484 | vitatron medical | HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA | July 24, 1985 |
| K844483 | vitatron medical | TP 1 | April 19, 1985 |
| K844485 | vitatron medical | CERYX6, 611, CERYX 3 311 & CERYX 1 111 | April 19, 1985 |
| K842364 | cardiac pacemakers | HANDHELD PACEMAKER PROGRAMMER & SOFTWAR | September 24, 1984 |
| K820230 | cardiac pacemakers | PACEMAKER PROGRAMMER 2030 | March 15, 1982 |
| K812761 | nova medical specialties | FLOW-DIRECTED BALLOON THERMODILUTION | November 2, 1981 |
| K812813 | intermedics | INTERMEDICS PROGRAMMER, MODEL 522-03 | October 27, 1981 |
| K811217 | cardiac pacemakers | PACEMAKER PROGRAMMER #2010 | July 20, 1981 |
| K810552 | cordis | CORDIS PACEMAKER PROGRAMMERS 255A & 256A | March 20, 1981 |
| K800376 | biotronik sales | EPR-200 PROGRAMMER MODEL 010 | April 21, 1980 |