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 |