B
If I am filing a traditional 510K that is intended to work with another device and that device has multiple 510K for different models.
The same exact product but been through changes, but each one is the same product but with a different aspect.
Example: a bike with spring suspension, sold as Huffy A1: Bike with a hydraulic suspension, Huffy Super A2: Bike with gas shocks: Huffy G1 etc...
For example, maybe not the best example in the world)
I want to file a 510K for a mobile swing arm xray to attach to an existing device like a patient bed. The patient bed has multiple 510k's cause it has different models. Lets say 6 models, so 6 different 510k numbers, same device, just different models.
What is the best way to say in my submission that my swing arm xray attaches to these 6 beds. All 6 beds are basically the same thing, they one may have a heating option so it has its own 510K, the other may have a hydarulic actuator so it has its own 510k etc...
Do I need to mention each 510K number constantly, or can I mention on a top level the model name and it's subsequent models?
Bearing in mind the manufacturer of these beds is somebody else
The same exact product but been through changes, but each one is the same product but with a different aspect.
Example: a bike with spring suspension, sold as Huffy A1: Bike with a hydraulic suspension, Huffy Super A2: Bike with gas shocks: Huffy G1 etc...
For example, maybe not the best example in the world)
I want to file a 510K for a mobile swing arm xray to attach to an existing device like a patient bed. The patient bed has multiple 510k's cause it has different models. Lets say 6 models, so 6 different 510k numbers, same device, just different models.
What is the best way to say in my submission that my swing arm xray attaches to these 6 beds. All 6 beds are basically the same thing, they one may have a heating option so it has its own 510K, the other may have a hydarulic actuator so it has its own 510k etc...
Do I need to mention each 510K number constantly, or can I mention on a top level the model name and it's subsequent models?
Bearing in mind the manufacturer of these beds is somebody else
Last edited by a moderator: