NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201
FDA 510(k) clearance K102376 · decided 2010-12-07
Clearance details
- K-number
- K102376
- Device name
- NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201
- Applicant
- Nihon Kohden Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-08-20
- Decision date
- 2010-12-07
- Days to decision
- 109 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Foothill, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac recall (Z-1979-2014) | Nihon Kohden America Inc | 2014-07-02 |