The following data is part of a premarket notification filed by Rfpi with the FDA for Icertainty.
| Device ID | K181269 |
| 510k Number | K181269 |
| Device Name: | ICertainty |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | Rfpi 1800 N Greene Street, Suite K Greenville, NC 27834 |
| Contact | Jeffery Basham |
| Correspondent | Jerzy Wojcik EdgeOne Medical 455 N Campbell Ave Chicago, IL 60612 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-14 |
| Decision Date | 2018-12-14 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ICERTAINTY 86419008 5513984 Live/Registered |
RFPi, LLC 2014-10-09 |