The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Response Diagnostic Electrophysiology Catheters.
| Device ID | K161827 |
| 510k Number | K161827 |
| Device Name: | Reprocessed Response Diagnostic Electrophysiology Catheters |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | INNOVATIVE HEALTH, LLC. 1435 NORTH HAYDEN ROAD SUITE 100 Scottsdale, AZ 85257 |
| Contact | Sharon Higgins |
| Correspondent | Rafal Chudzik INNOVATIVE HEALTH, LLC. 1435 NORTH HAYDEN ROAD SUITE 100 Scottsdale, AZ 85257 |
| Product Code | NLH |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-05 |
| Decision Date | 2016-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898113703 | K161827 | 000 |
| 10841898113574 | K161827 | 000 |
| 10841898113819 | K161827 | 000 |
| 10841898113796 | K161827 | 000 |
| 10841898113727 | K161827 | 000 |
| 10841898113666 | K161827 | 000 |
| 10841898113642 | K161827 | 000 |
| 10841898113604 | K161827 | 000 |
| 10841898113581 | K161827 | 000 |
| 10841898113550 | K161827 | 000 |
| 10841898113598 | K161827 | 000 |
| 10841898113628 | K161827 | 000 |
| 10841898113680 | K161827 | 000 |
| 10841898113673 | K161827 | 000 |
| 10841898113659 | K161827 | 000 |
| 10841898113543 | K161827 | 000 |
| 10841898113536 | K161827 | 000 |
| 10841898113482 | K161827 | 000 |
| 10841898113826 | K161827 | 000 |
| 10841898113802 | K161827 | 000 |
| 10841898113734 | K161827 | 000 |
| 10841898113512 | K161827 | 000 |