Central Station 590
FDA 510(k) K830432 · Kone Instruments, Inc.
510(k) numberK830432
Submission
- Device name
- Central Station 590
- Applicant
- Kone Instruments, Inc.
Mchenry, IL, US - Received
- February 9, 1983
- Decision date
- March 24, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code DRT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261286 | The Circadia C300 System (C300)DRT · Special | Circadia Health, Inc. | 05/20/2026SE |
| K252676 | The Circadia C300 System (C300)DRT · Traditional | Circadia Health, Inc. | 02/03/2026SE |
| K253388 | Sleepiz One+ (Model 2.5)DRT · Special | Sleepiz AG | 01/28/2026SE |
| K251364 | Sleepiz One+ (2.5)DRT · Special | Sleepiz AG | 07/29/2025SE |
| K234003 | The Circadia C200 SystemDRT · Traditional | Circadia Technologies, Ltd. | 05/30/2024SE |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server…DRT · Traditional | Murata Vios, Inc. | 03/22/2024SE |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring SensorDRT · Traditional | Neteera Technologies , Ltd. | 02/09/2024SE |
| K223163 | Sleepiz One+DRT · Traditional | Sleepiz AG | 08/18/2023SE |
| K212143 | Neteera 130H/131H Vital Sign Monitoring SensorDRT · Traditional | Neteera Technologies , Ltd. | 09/28/2022SE |
| K202138 | Cardiac Trigger MonitorDRT · Traditional | Ivy Biomedical Systems, Inc. | 05/14/2021SE |
More from Ivy Biomedical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873345 | 'Microlyte 4/5'JFP · Traditional | 09/11/1987SE |
| K870777 | Progress Plus Selective Chemistry AnalyzerJJF · Traditional | 03/13/1987SE |
| K863466 | M700 Stress MonitorDRT · Traditional | 12/22/1986SE |
| K862655 | Signa II Resting ECG ElectrodeDRX · Traditional | 08/06/1986SE |
| K860767 | Model E 600 ElectrocardiographDSI · Traditional | 04/23/1986SE |
| K853354 | Medic 4LDD · Traditional | 10/11/1985SE |
| K840200 | Progress Selective Dhemistry AnalyzJJF · Traditional | 04/04/1984SE |
| K830433 | Patient Monitor 575DRT · Traditional | 03/24/1983SE |
| K822952 | 560DRT · Traditional | 11/01/1982SE |
| K820541 | MicrolyteJJF · Traditional | 05/24/1982SE |
Questions and answers
When was Central Station 590 cleared by the FDA?
Central Station 590 (K830432) received a 510(k) decision of Substantially Equivalent on March 24, 1983, 43 days after the submission was received.
What is the product code of K830432?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.