LM2000A SURGICAL SUCTION MONITOR— 510(k) K854359

Substantially Equivalent

Engineering, Inc.

FDA 510(k) clearance K854359 for LM2000A SURGICAL SUCTION MONITOR, Substantially Equivalent on 1986-03-03. Applicant: Engineering, Inc..

Clearance details

Applicant: Engineering, Inc.
Product code: Code KDQ
Advisory panel: General Hospital
Date received: 1985-10-29
Decision date: 1986-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDQ

product code KDQ

Death: 8
Malfunction: 637
Total: 645

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.