The following data is part of a premarket notification filed by Hemametrics with the FDA for Crit-line Monitor Iii Tqa (clm Tqa).
| Device ID | K011741 |
| 510k Number | K011741 |
| Device Name: | CRIT-LINE MONITOR III TQA (CLM TQA) |
| Classification | System, Dialysate Delivery, Single Pass |
| Applicant | HEMAMETRICS 695 NORTH, 900 WEST Kaysville, UT 84037 |
| Contact | Matthew L Haynie |
| Correspondent | Matthew L Haynie HEMAMETRICS 695 NORTH, 900 WEST Kaysville, UT 84037 |
| Product Code | FIL |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-05 |
| Decision Date | 2002-07-23 |
| Summary: | summary |