HEMATOCRIT-SATURATION MONITOR HSM-100— 510(k) K852124

Substantially Equivalent

American Bentley

FDA 510(k) clearance K852124 for HEMATOCRIT-SATURATION MONITOR HSM-100, Substantially Equivalent on 1985-09-16. Applicant: American Bentley.

Clearance details

Applicant: American Bentley
Product code: Code DRY
Advisory panel: Cardiovascular
Date received: 1985-05-15
Decision date: 1985-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.