NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION— 510(k) K102106

Substantially Equivalent

Nihon Kohden Corp.

FDA 510(k) clearance K102106 for NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION, Substantially Equivalent on 2010-12-17. Applicant: Nihon Kohden Corp..

Clearance details

Applicant
Nihon Kohden Corp.
Product code
Code DRG
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Foothill, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DRG

product code DRG
Death
5
Total
5

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.