510(k) K001763
- Device
- CRIT-LINE MONITOR III (CLM III)
- Applicant
- IN-LINE DIAGNOSTICS CORP.
- 510(k) number
- K001763
- Product code
- MQS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-12-20
- Date received
- 2000-06-12
- Regulation
- 876.5820
- Classification name
- System, Hemodialysis, Access Recirculation Monitoring
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MATTHEW L HAYNIE
- Address
- 695 N. 900 W. Kaysville UT US 84037 84037
FDA Registration Numbers#
- 1225714
- 3010728384
- 1319030
Source Documents#
Other 510(k) Records For Product Code MQS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232283 | PhySoftAMS® | Physician Software Systems, LLC | 2023-12-14 |
| K180410 | Dosis SAM | Dosis, Inc. | 2019-01-16 |
| K130579 | PHYSOFT AMS | Physicians Software Systems, LLC | 2013-12-19 |
| K042566 | VASC-ALERT | Vasc-Alert, Inc. | 2004-11-08 |
| K022963 | TRANSONIC SYRINGE WARMER, MODEL SYR-1000 | Transonic Systems, Inc. | 2002-12-04 |
| K021571 | TRANSONIC FLOW-QC SET MODEL ADT1010 | Transonic Systems, Inc. | 2002-08-12 |
| K993587 | HP M2376A DEVICE LINK SYSTEM | Hewlett-Packard Co. | 2000-01-20 |
| K992227 | CRIT-LINE MONITOR III (CLM III) | In-Line Diagnostics Corp. | 1999-07-30 |
| K984194 | HP M2376A DEVICE LINK SYSTEM | Hewlett-Packard Co. | 1999-04-30 |
| K982412 | MODIFICATION OF CRIT-LINE MONITOR III (CLM III) | In-Line Diagnostics Corp. | 1998-10-09 |
| K980906 | TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO | Transonic Systems, Inc. | 1998-10-06 |
| K972470 | CRIT-LINE MONITOR (CLMIII) | In-Line Diagnostics Corp. | 1997-12-11 |
| K960817 | HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) | Transonic Systems, Inc. | 1997-02-11 |
| K954003 | COBE HEMODYNAMIC RECIRCULATION MONITOR | Cobe Renal Care, Inc. | 1997-02-06 |
| K953875 | CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) | In-Line Diagnostics Corp. | 1996-07-23 |
Legacy Summary#
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FDA Review#
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