Modification of: Physiological Signal Transmitter and Receiver, Model 3810A
FDA 510(k) K993169 · Hewlett-Packard Co.
510(k) numberK993169
Submission
- Device name
- Modification of: Physiological Signal Transmitter and Receiver, Model 3810A
- Applicant
- Hewlett-Packard Co.
Los Altos, CA, US - Received
- September 22, 1999
- Decision date
- December 20, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
Other 510(k)s with product code DRG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261569 | UbiqVue 2AYe Cardiac System (UX2253)DRG · Traditional | Lifesignals, Inc. | 07/09/2026SE |
| K252984 | Perin Health System (PHD80060-2)DRG · Traditional | Perin Health Devices, LLC | 01/22/2026SE |
| K252440 | EasyTeleMed (2.0.2)DRG · Traditional | Ingeniars S.R.L. | 10/02/2025SE |
| K250259 | TeleRehab Aermos Cardiopulmonary RehabilitationDRG · Traditional | The ScottCare Corporation | 06/04/2025SE |
| K243837 | iBSMDRG · Traditional | Iorbit Digital Technologies Private Limited | 05/16/2025SE |
| K242018 | UbiqVue 2A Multi-parameter System (UX2550)DRG · Traditional | Lifesignals, Inc. | 11/12/2024SE |
| K241101 | BioButton SystemDRG · Traditional | Biointellisense, Inc. | 09/26/2024SE |
| K240251 | ANNE ChestDRG · Traditional | Sibel Health, Inc. | 06/03/2024SE |
| K223711 | ANNE OneDRG · Traditional | Sibel Health, Inc. | 08/10/2023SE |
| K220526 | HD+12, HD+15DRG · Traditional | Cardioline S.P.A | 05/15/2023SE |
More from Cardioline S.P.A
| 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 |
| 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 |
| K992636 | HP Carevue 9000 Clinical Information System, Model M2331ADXJ · Special | 08/31/1999SE |
Questions and answers
When was Modification of: Physiological Signal Transmitter and Receiver, Model 3810A cleared by the FDA?
Modification of: Physiological Signal Transmitter and Receiver, Model 3810A (K993169) received a 510(k) decision of Substantially Equivalent on December 20, 1999, 89 days after the submission was received.
What is the product code of K993169?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.