HP M2600A Viridia Telemetry System
FDA 510(k) K993516 · Hewlett-Packard Co.
510(k) numberK993516
Submission
- Device name
- HP M2600A Viridia Telemetry System
- Applicant
- Hewlett-Packard Co.
Andover, MA, US - Received
- October 18, 1999
- Decision date
- November 8, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0)DSI · Traditional | Boston Scientific Cardiac Diagnostic… | 01/23/2026SE |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional | Infobionic, Inc. | 07/29/2025SE |
| K240177 | Zio AT® device (A100A1001)DSI · Traditional | iRhythm Technologies, Inc. | 10/30/2024SE |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
| K231276 | SmartCardia 7L PlatformDSI · Traditional | Smartcardia SA | 08/30/2023SE |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special | Medicalgorithmics S.A. | 04/09/2020SE |
| K192732 | BodyGuardian Remote Monitoring SystemDSI · Traditional | Preventice Technologies, Inc. | 03/26/2020SE |
| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
| K182532 | Liba3 SystemDSI · Traditional | National Cardiac, Inc. | 05/15/2019SE |
| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
More from Memtec Corporation
| 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 |
| 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 |
| K992636 | HP Carevue 9000 Clinical Information System, Model M2331ADXJ · Special | 08/31/1999SE |
Questions and answers
When was HP M2600A Viridia Telemetry System cleared by the FDA?
HP M2600A Viridia Telemetry System (K993516) received a 510(k) decision of Substantially Equivalent on November 8, 1999, 21 days after the submission was received.
What is the product code of K993516?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.