Model 255A Programmer III, W/Software Revi. 4004
FDA 510(k) K882429 · Tpl-Cordis, Inc.
510(k) numberK882429
Submission
- Device name
- Model 255A Programmer III, W/Software Revi. 4004
- Applicant
- Tpl-Cordis, Inc.
Englewood, CO, US - Received
- June 14, 1988
- Decision date
- July 22, 1988
- 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 |
| K864712 | Model 1740 Personal Pocket ProgrammerKRG · Traditional | Telectronics, Inc. | 12/17/1987SE |
| 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 |
|---|---|---|
| K885240 | Modified Ancor & Hi-Flex Unipolar Active Fix. LeadDTB · Traditional | 02/10/1989SE |
| K880898 | Multicor and PacemakersDXY · Traditional | 05/06/1988SE |
| K880432 | Vicor Pacer, Model 410ADXY · Traditional | 02/22/1988SE |
| K873158 | Modified Multicor and Omni-Stanicor PacemakersDXY · Traditional | 01/07/1988SE |
| K873202 | Vicor, Model 410ADXY · Traditional | 10/15/1987SE |
Questions and answers
When was Model 255A Programmer III, W/Software Revi. 4004 cleared by the FDA?
Model 255A Programmer III, W/Software Revi. 4004 (K882429) received a 510(k) decision of Substantially Equivalent on July 22, 1988, 38 days after the submission was received.
What is the product code of K882429?
The FDA product code is KRG – Programmer, Pacemaker, a Class III (high risk) device regulated under 21 CFR 870.3700.