CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES— 510(k) K023475
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K023475 for CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES, Substantially Equivalent on 2002-10-24. Applicant: Nihon Kohden America, Inc..
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- Product code
- Code MHX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Foothill, CA, US
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
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.