HP M2376A Device Link System
FDA 510(k) K984194 · Hewlett-Packard Co.
510(k) numberK984194
Submission
- Device name
- HP M2376A Device Link System
- Applicant
- Hewlett-Packard Co.
Andover, MA, US - Received
- November 23, 1998
- Decision date
- April 30, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQS – System, Hemodialysis, Access Recirculation Monitoring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K232283 | PhySoftAMS®MQS · Traditional | Physician Software Systems, LLC | 12/14/2023SE |
| K180410 | Dosis SAMMQS · Traditional | Dosis, Inc. | 01/16/2019SE |
| K130579 | Physoft AmsMQS · Traditional | Physicians Software Systems, LLC | 12/19/2013SE |
| K042566 | Vasc-AlertMQS · Traditional | Vasc-Alert, Inc. | 11/08/2004SE |
| K022963 | Transonic Syringe Warmer, Model SYR-1000MQS · Traditional | Transonic Systems, Inc. | 12/04/2002SE |
| K021571 | Transonic Flow-Qc Set Model ADT1010MQS · Traditional | Transonic Systems, Inc. | 08/12/2002SE |
| K001763 | Crit-Line Monitor III (CLM III)MQS · Traditional | In-Line Diagnostics Corp. | 12/20/2000SE |
| K993587 | HP M2376A Device Link SystemMQS · Traditional | Hewlett-Packard Co. | 01/20/2000SE |
| K992227 | Crit-Line Monitor III (CLM III)MQS · Special | In-Line Diagnostics Corp. | 07/30/1999SE |
| K982412 | Modification of Crit-Line Monitor III (CLM III)MQS · Traditional | In-Line Diagnostics Corp. | 10/09/1998SE |
More from In-Line Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K992543 | Heartstream XLT Defibrillator/Monitor, Ac Charger, DC Charger, Data Card, Single Bay…MKJ · Traditional | 05/18/2000SE |
| K993383 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A…DSI · Abbreviated | 02/03/2000SE |
| K992273 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…MHX · Abbreviated | 01/28/2000SE |
| K993587 | HP M2376A Device Link SystemMQS · Traditional | 01/20/2000SE |
| K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810ADRG · Traditional | 12/20/1999SE |
| K992595 | HP Viridia Component Monitoring System, Model Rev. K with Easi-St Segment Measurement…MHX · Special | 12/08/1999SE |
| K992977 | Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504AMKJ · Traditional | 12/01/1999SE |
| K993516 | HP M2600A Viridia Telemetry SystemDSI · Special | 11/08/1999SE |
| K992674 | HP Viridia CMS Patient Monitor with EEG Parameter, Model M1027AMHX · Abbreviated | 11/08/1999SE |
| K993171 | HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154ADSI · Special | 10/21/1999SE |
Questions and answers
When was HP M2376A Device Link System cleared by the FDA?
HP M2376A Device Link System (K984194) received a 510(k) decision of Substantially Equivalent on April 30, 1999, 158 days after the submission was received.
What is the product code of K984194?
The FDA product code is MQS – System, Hemodialysis, Access Recirculation Monitoring, a Class II (moderate risk) device regulated under 21 CFR 876.5820.