INTERMED, INS STERILE WATER/SALINE— 510(k) K842166

Substantially Equivalent

Intermed, Inc.

FDA 510(k) clearance K842166 for INTERMED, INS STERILE WATER/SALINE, Substantially Equivalent on 1985-02-12. Applicant: Intermed, Inc..

Clearance details

Applicant: Intermed, Inc.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1984-05-31
Decision date: 1985-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparta, NJ, 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.