HYDRAMED BY LECHLER— 510(k) K882953

Substantially Equivalent

Lechler, Inc.

FDA 510(k) clearance K882953 for HYDRAMED BY LECHLER, Substantially Equivalent on 1988-10-12. Applicant: Lechler, Inc..

Clearance details

Applicant: Lechler, Inc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1988-07-14
Decision date: 1988-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Charles, IL, US

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.