CAL-COUNT— 510(k) K801868

Substantially Equivalent

Bayshore Systems Corp.

FDA 510(k) clearance K801868 for CAL-COUNT, Substantially Equivalent on 1980-08-27. Applicant: Bayshore Systems Corp..

Clearance details

Applicant: Bayshore Systems Corp.
Product code: Code ISD
Advisory panel: Physical Medicine
Date received: 1980-08-05
Decision date: 1980-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

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.