Nihon Kohden SVM-7200 Series Vital Signs Monitor— 510(k) K190468
Substantially EquivalentNihon Kohden Corporation
FDA 510(k) clearance K190468 for Nihon Kohden SVM-7200 Series Vital Signs Monitor, Substantially Equivalent on 2019-05-28. Applicant: Nihon Kohden Corporation. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden Corporation
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code MWI
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- K260747 — YP-710T Series NIBP Cuff; YP-840T Series Disposable Cuff
- K251366 — EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
- K243956 — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
- K223567 — CNS-2101 Central Monitor
Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.