The following data is part of a premarket notification filed by Noninvasive Medical Technology Corp. with the FDA for Crit-line.
Device ID | K924167 |
510k Number | K924167 |
Device Name: | CRIT-LINE |
Classification | Device, Hematocrit Measuring |
Applicant | NONINVASIVE MEDICAL TECHNOLOGY CORP. 333 SECOND STREET, SUITE 8 Ogden, UT 84404 |
Contact | James M Coinis |
Correspondent | James M Coinis NONINVASIVE MEDICAL TECHNOLOGY CORP. 333 SECOND STREET, SUITE 8 Ogden, UT 84404 |
Product Code | JPI |
CFR Regulation Number | 864.6400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-19 |
Decision Date | 1993-05-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CRIT-LINE 75036561 2038523 Live/Registered |
FRESENIUS MEDICAL CARE HOLDINGS, INC. 1995-12-26 |
CRIT-LINE 74571958 not registered Dead/Abandoned |
In-Line Diagnostics Corporation 1994-09-12 |
CRIT-LINE 74342477 not registered Dead/Abandoned |
Non-Invasive Medical Technology Corporation 1992-12-14 |