Dialog Programmer 700 - Program Version 6.37
FDA 510(k) K860546 · Pacesetter Systems
510(k) numberK860546
Submission
- Device name
- Dialog Programmer 700 - Program Version 6.37
- Applicant
- Pacesetter Systems
Sylmar, CA, US - Received
- February 13, 1986
- Decision date
- April 23, 1986
- 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 |
| 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 |
| 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 |
|---|---|---|
| K910924 | Endocardial Leads-Mod. to the PolyvinylpyrrolidoneDTB · Traditional | 08/28/1991SE |
| K902147 | Endocardial Screw-In Lead Model 1028TDTB · Traditional | 07/17/1990SE |
| K900512 | Siemens Elema Models 4020T and 4021T AdaptersDTD · Traditional | 06/25/1990SE |
| K900550 | Fast-Pass Ace Models 1212T/1222T/1216T/1226TDTB · Traditional | 04/20/1990SE |
| K895447 | Endocardial Screw-In Lead Model 1020TDTB · Traditional | 12/20/1989SE |
| K891905 | Cardiovascular Permanent Pacemaker ElectrodeDTB · Traditional | 06/05/1989SE |
| K885267 | VS-1 Model Number 251K Pulse GeneratorDXY · Traditional | 03/28/1989SE |
| K890547 | Siemens Elema Models 4025 and 4026 AdaptersDTB · Traditional | 03/22/1989SE |
| K884733 | Afp Model 262T Pulse GeneratorDXY · Traditional | 02/10/1989SE |
| K883087 | Prolog MP 658M Pulse GeneratorDXY · Traditional | 09/14/1988SE |
Questions and answers
When was Dialog Programmer 700 - Program Version 6.37 cleared by the FDA?
Dialog Programmer 700 - Program Version 6.37 (K860546) received a 510(k) decision of Substantially Equivalent on April 23, 1986, 69 days after the submission was received.
What is the product code of K860546?
The FDA product code is KRG – Programmer, Pacemaker, a Class III (high risk) device regulated under 21 CFR 870.3700.