Model 1740 Personal Pocket Programmer
FDA 510(k) K864712 · Telectronics, Inc.
510(k) numberK864712
Submission
- Device name
- Model 1740 Personal Pocket Programmer
- Applicant
- Telectronics, Inc.
Suffield, CT, US - Received
- December 3, 1986
- Decision date
- December 17, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRG – Programmer, Pacemaker
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.3700
- Specialty
- Cardiovascular
Other 510(k)s with product code KRG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933278 | Intermedics Triangle Chest Probe Model 526-04KRG · Traditional | Intermedics, Inc. | 03/15/1995SE |
| K884522 | Model 5650 Optimate Personal ProgrammerKRG · Traditional | Teletronics, Inc. | 08/25/1989SE |
| K880738 | Model 2331T Patient ProgrammerKRG · Traditional | Medtronic Vascular | 11/17/1988SE |
| K882429 | Model 255A Programmer III, W/Software Revi. 4004KRG · Traditional | Tpl-Cordis, Inc. | 07/22/1988SE |
| K871986 | Model 5600B Programmer, PacemakerKRG · Traditional | Telectronics, Inc. | 06/24/1987SE |
| K863046 | Ultra Software Module: Model 2016KRG · Traditional | Cardiac Pacemakers, Inc. | 12/05/1986SE |
| K863045 | Programmer Model 2035/ELECTROGRAM Cable Model 6580KRG · Traditional | Cardiac Pacemakers, Inc. | 09/29/1986SE |
| K860584 | Software MODULE/2035 Prog and Astra/T Pulse GenKRG · Traditional | Cardiac Pacemakers, Inc. | 06/06/1986SE |
| K860546 | Dialog Programmer 700 - Program Version 6.37KRG · Traditional | Pacesetter Systems | 04/23/1986SE |
| K844484 | Hewlett Packardt HP 85 W/ Vitatron PH1 Program HeaKRG · Traditional | Vitatron Medical BV | 07/24/1985SE |
More from Vitatron Medical BV
| 510(k) | Device | Decision |
|---|---|---|
| K890895 | Implantable Adaptor 033-380DTD · Traditional | 03/06/1990SE |
| K891231 | Optima MPT and SPT PacemakersDXY · Traditional | 09/12/1989SE |
| K890350 | VS-1 Silicone Implant Leads (New Serial # Tube)DTB · Traditional | 02/02/1989SE |
| K884411 | Optima MPT and SPT PacemakersDXY · Traditional | 01/26/1989SE |
| K884278 | Implantable Electrode Leads 033-400,402 and 436DTB · Traditional | 12/15/1988SE |
| K881837 | Optima MPT Series III Pacemaker, 5281D and 5282DDXY · Traditional | 07/18/1988SE |
| K874664 | Implantable Electrode Lead, Model 030-446DTB · Traditional | 05/31/1988SE |
| K872766 | Implantable Programmable Cardiac Pulse GeneratorsDXY · Traditional | 11/04/1987SE |
| K865098 | Slimline Unipolar Endocardial Pacing Lead, 030-438DTB · Traditional | 08/18/1987SE |
| K871992 | Implantable Programmable Cardiac Pulse GeneratorsDXY · Traditional | 08/12/1987SE |
Questions and answers
When was Model 1740 Personal Pocket Programmer cleared by the FDA?
Model 1740 Personal Pocket Programmer (K864712) received a 510(k) decision of Substantially Equivalent on December 17, 1987, 379 days after the submission was received.
What is the product code of K864712?
The FDA product code is KRG – Programmer, Pacemaker, a Class III (high risk) device regulated under 21 CFR 870.3700.