Identify appropriate predicate devices establishing substantial equivalence foundation for successful clearance submissions.
Device Trade Name | Submission Number | Product Code | Description |
---|---|---|---|
Zio XT Patch | K143254 | MYN | Single-channel ambulatory ECG monitor for continuous recording - provides reference for extended monitoring capability |
Apple Watch Series 4 ECG | K182749 | MYN | Wearable ECG device with mobile app - provides reference for wearable form factor and consumer use |
What makes a good predicate device for my 510(k) submission?
Can I use multiple predicate devices in my 510(k) submission?
What if my device has new technological characteristics compared to predicates?
How do I find appropriate predicate devices for my submission?
What if no predicate device exists for my novel technology?
How detailed should my predicate comparison be in the 510(k) submission?