SIEMENS SIRECUST 404N NEONATAL MONITOR— 510(k) K844187

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K844187 for SIEMENS SIRECUST 404N NEONATAL MONITOR, Substantially Equivalent on 1985-04-11. Applicant: Siemens Medical Solutions USA, Inc..

Clearance details

Applicant
Siemens Medical Solutions USA, Inc.
Product code
Code DRT
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Englewood, CO, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DRT

product code DRT
Death
4
Total
4

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.