The following data is part of a premarket notification filed by Diversatek Healthcare with the FDA for Diversatek Healthcare High Resolution Impedance Manometry (hrim) Probe.
| Device ID | K190208 |
| 510k Number | K190208 |
| Device Name: | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | Diversatek Healthcare 9150 Commerce Center Circle Suite 500 Highlands Ranch, CO 80129 |
| Contact | Laura L. Boll |
| Correspondent | Laura L. Boll Diversatek Healthcare 9150 Commerce Center Circle Suite 500 Highlands Ranch, CO 80129 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-04 |
| Decision Date | 2019-10-03 |