Type 9220 Press 1 & 2 System Athena
FDA 510(k) K884118 · S & W Medico Teknik
510(k) numberK884118
Submission
- Device name
- Type 9220 Press 1 & 2 System Athena
- Applicant
- S & W Medico Teknik
Denmark, DK - Received
- September 30, 1988
- Decision date
- April 25, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSK – Computer, Blood-Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1110
- Specialty
- Cardiovascular
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|---|---|---|---|
| K231586 | Endophys Blood Pressure Monitor model BPM-30DSK · Traditional | Endophys Technologies, LLC | 11/03/2023SE |
| K160945 | Endophys Blood Pressure MonitorDSK · Traditional | Endophys Holdings, LLC | 09/26/2016SE |
| K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxDSK · Special | Volcano Corporation | 12/03/2015SE |
| K141615 | Endophys Blood Pressure MonitorDSK · Traditional | Endophys, Inc. | 01/07/2015SE |
| K080670 | Modification to Sphygmocor Cardiovascular Management SystemDSK · Special | Atcor Medical | 04/23/2008SE |
| K070795 | Sphygmocor Cardiovascular Management SystemDSK · Traditional | Atcor Medical Pty, Ltd. | 08/31/2007SE |
| K033738 | Monitoring System, Model Argus PB-2200DSK · Traditional | Schiller AG | 08/24/2004SE |
| K021517 | Abp for WindowsDSK · Traditional | Rozinn Electronics, Inc. | 07/24/2002SE |
| K013943 | Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720DSK · Special | Radi Medical Systems AB | 12/18/2001SE |
| K011865 | Zoll M Series Ibp Operation; Zoll M Series Temperature OptionDSK · Traditional | Zoll Medical Corp | 07/31/2001SE |
More from Zoll Medical Corp
| 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 |
| K911611 | System Athena, ModificationDRT · Traditional | 02/05/1993SE |
| 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 |
Questions and answers
When was Type 9220 Press 1 & 2 System Athena cleared by the FDA?
Type 9220 Press 1 & 2 System Athena (K884118) received a 510(k) decision of Substantially Equivalent on April 25, 1989, 207 days after the submission was received.
What is the product code of K884118?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.