Medilog Optima
FDA 510(k) K896535 · Oxford Medilog, Inc.
510(k) numberK896535
Submission
- Device name
- Medilog Optima
- Applicant
- Oxford Medilog, Inc.
Clearwater, FL, US - Received
- November 14, 1989
- Decision date
- January 18, 1990
- 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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| 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 |
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| K923737 | Model Medilog RapideBZQ · Traditional | 01/05/1994SE |
| K920295 | Medilog Excel ECG Analysis System (Modified)DQK · Traditional | 08/18/1992SE |
| K912890 | Model Sonicaid AxisHGM · Traditional | 01/09/1992SE |
| K912639 | Sonicaid TeamHGM · Traditional | 12/31/1991SE |
| K904763 | Mentor EEG SystemGWQ · Traditional | 04/10/1991SE |
| K902690 | Sonicaid Model Meridian 800HGM · Traditional | 02/05/1991SE |
| K895909 | Sonicaid Model Vasoflo 4MAA · Traditional | 07/09/1990SE |
| K891383 | Medilog 9200 EEG Replay/Analysis SystemOLZ · Traditional | 06/01/1989SE |
| K890330 | Medilog 6000-FD Report GeneratorDSI · Traditional | 04/20/1989SE |
| K890338 | Medilog EditorDSI · Traditional | 04/19/1989SE |
Questions and answers
When was Medilog Optima cleared by the FDA?
Medilog Optima (K896535) received a 510(k) decision of Substantially Equivalent on January 18, 1990, 65 days after the submission was received.
What is the product code of K896535?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.