REPRO-MED NEONATE ASPIRATION SYSTEM— 510(k) K892529

Substantially Equivalent

Repro-Med Systems, Inc.

FDA 510(k) clearance K892529 for REPRO-MED NEONATE ASPIRATION SYSTEM, Substantially Equivalent on 1989-06-12. Applicant: Repro-Med Systems, Inc..

Clearance details

Applicant: Repro-Med Systems, Inc.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1989-04-11
Decision date: 1989-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middletown, NY, 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.