CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1— 510(k) K031086

Substantially Equivalent

Integra Neurosciences

FDA 510(k) clearance K031086 for CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1, Substantially Equivalent on 2003-05-14. Applicant: Integra Neurosciences.

Clearance details

Applicant: Integra Neurosciences
Product code: Code GWM
Advisory panel: Neurology
Date received: 2003-04-07
Decision date: 2003-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

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.