MECONIUM ASPIRATOR— 510(k) K871407

Substantially Equivalent

Intertech Resources, Inc.

FDA 510(k) clearance K871407 for MECONIUM ASPIRATOR, Substantially Equivalent on 1987-06-15. Applicant: Intertech Resources, Inc..

Clearance details

Applicant: Intertech Resources, Inc.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1987-04-08
Decision date: 1987-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Myers, FL, US

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Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.