System Athena, Modification
FDA 510(k) K911611 · S & W Medico Teknik
510(k) numberK911611
Submission
- Device name
- System Athena, Modification
- Applicant
- S & W Medico Teknik
Denmark, DK - Received
- April 9, 1991
- Decision date
- February 5, 1993
- 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
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| 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 |
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| 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 |
|---|---|---|
| K940933 | 9267 SPO2 Athena ModuleDQA · Traditional | 11/29/1995SE |
| K913013 | TCPO2 9260 Module - System AthenaLKD · Traditional | 05/03/1994SE |
| K915633 | Mod. Type 9230 Temp 1 and Temp 2 System AthenaFLL · Traditional | 06/29/1993SE |
| K930134 | 9055 Irca Option for System Athena 9050 NTDPS · Traditional | 04/09/1993SE |
| K923418 | 9293/1 Interface ModuleDQA · Traditional | 02/23/1993SE |
| K922314 | Ventilator Interface 9291/4CBK · Traditional | 12/17/1992SE |
| K912815 | Nibp 9225 CombiDXN · Traditional | 10/09/1992SE |
| K912000 | Type Interface 9271/1 Incubator/WarmerFMZ · Traditional | 09/21/1992SE |
| K912183 | Type 9050/NEODPS · Traditional | 06/23/1992SE |
| K912145 | System Athena-Product Enhancements, AnesthesiaCCE · Traditional | 05/05/1992SE |
Questions and answers
When was System Athena, Modification cleared by the FDA?
System Athena, Modification (K911611) received a 510(k) decision of Substantially Equivalent on February 5, 1993, 668 days after the submission was received.
What is the product code of K911611?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.