Storage, Digital DSC-1, Control Unit
FDA 510(k) K790288 · Oxford Medilog, Inc.
510(k) numberK790288
Submission
- Device name
- Storage, Digital DSC-1, Control Unit
- Applicant
- Oxford Medilog, Inc.
Mchenry, IL, US - Received
- February 8, 1979
- Decision date
- February 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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| K181372 | ArgosDXG · Traditional | Retia Medical, LLC | 12/13/2018SE |
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| K163334 | LiDCOunity v2 Hemodynamic MonitorDXG · Traditional | Lidco, Ltd. | 06/05/2017SE |
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| 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 |
| K896535 | Medilog OptimaDSK · Traditional | 01/18/1990SE |
| K891383 | Medilog 9200 EEG Replay/Analysis SystemOLZ · Traditional | 06/01/1989SE |
| K890330 | Medilog 6000-FD Report GeneratorDSI · Traditional | 04/20/1989SE |
Questions and answers
When was Storage, Digital DSC-1, Control Unit cleared by the FDA?
Storage, Digital DSC-1, Control Unit (K790288) received a 510(k) decision of Substantially Equivalent on February 27, 1979, 19 days after the submission was received.
What is the product code of K790288?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.