MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A— 510(k) K883973

Substantially Equivalent

Nihon Kohden America, Inc.

FDA 510(k) clearance K883973 for MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A, Substantially Equivalent on 1988-11-09. Applicant: Nihon Kohden America, Inc..

Clearance details

Applicant: Nihon Kohden America, Inc.
Product code: Code DXJ
Advisory panel: Cardiovascular
Date received: 1988-09-20
Decision date: 1988-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.