510(k) K950464— SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES

Substantially Equivalent

Sscor

Clearance details

Applicant: Sscor
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1995-02-03
Decision date: 1995-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sun Valley, CA, US

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.