The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Halo Xp Diagnostic Electrophysiology Catheter.
| Device ID | K171788 |
| 510k Number | K171788 |
| Device Name: | Reprocessed Halo XP Diagnostic Electrophysiology Catheter |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Contact | Amy Stoklas-oakes |
| Correspondent | Amy Stoklas-oakes 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 | 2017-06-15 |
| Decision Date | 2017-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898123160 | K171788 | 000 |
| 10841898123177 | K171788 | 000 |