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 |