MLC-4200 CARDIAC OUTPUT COMPUTER— 510(k) K802305
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K802305 for MLC-4200 CARDIAC OUTPUT COMPUTER, Substantially Equivalent on 1980-10-10. Applicant: Nihon Kohden America, Inc.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- Product code
- Code DXG
- Device class
- Class 2
- Regulation
- 21 CFR 870.1435
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foothill, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.