FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
K Number: K982412
·
Decision Oct 9, 1998
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
17
Applicant Total
8
Review Days
88
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Basic Information
- Device Name
- MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
- K Number
- K982412
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- In-Line Diagnostics Corp.
- Date Received
- July 13, 1998
- Decision Date
- October 9, 1998
- Product Code
- MQS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQS | System, Hemodialysis, Access Recirculation Monitoring | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by In-Line Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K001763 | CRIT-LINE MONITOR III (CLM III) | Dec 20, 2000 | Substantially Equivalent |
| K992227 | CRIT-LINE MONITOR III (CLM III) | Jul 30, 1999 | Substantially Equivalent |
| K983551 | CRIT-SCAN II MONITOR | May 27, 1999 | Substantially Equivalent |
| K972470 | CRIT-LINE MONITOR (CLMIII) | Dec 11, 1997 | Substantially Equivalent |
| K953875 | CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) | Jul 23, 1996 | Substantially Equivalent |
| K950942 | CRIT-LINE HEMATOCRIT ALERT | Mar 14, 1995 | Substantially Equivalent |
| K935958 | CRIT-LINE BLOOD CHAMBER WITH E-BEAM | Jan 19, 1995 | Substantially Equivalent |