Teletronics, Inc.
Country not established
- Devices
- 1
What Teletronics, Inc. makes
Teletronics, Inc. manufactures the Model 5650 Optimate Personal Programmer, a device designed for programming and configuring implantable cardiac devices such as pacemakers and defibrillators. This tool supports diagnostic and therapeutic adjustments for patient-specific device settings.
The company’s portfolio is regulated under FDA Class III devices, requiring premarket approval (PMA) or a 510(k) clearance. The Model 5650 Optimate Personal Programmer is listed under the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Model 5650 Optimate Personal Programmer Ref K884522
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Teletronics, Inc. have in the registry?
The registry currently lists 1 device for Teletronics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Teletronics, Inc.'s devices?
Among its 1 most recently registered device, Teletronics, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Teletronics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Teletronics, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Teletronics, Inc. in the registry?
The most recently registered devices listed for Teletronics, Inc. include MODEL 5650 OPTIMATE PERSONAL PROGRAMMER.