NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201— 510(k) K102376
Substantially EquivalentNihon Kohden Corp.
FDA 510(k) clearance K102376 for NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201, Substantially Equivalent on 2010-12-07. Applicant: Nihon Kohden Corp.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden Corp.
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Foothill, CA, US
Recent devices under product code MHX
view allMore clearances from Nihon Kohden Corp.
view allAdverse 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 →
Recalls naming K102376
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102376.
Data sourced from openFDA. This site is unofficial and independent of the FDA.