NEOGUARD CHEST PERCUSSOR— 510(k) K853965

Substantially Equivalent

Cas Medical Systems, Inc.

FDA 510(k) clearance K853965 for NEOGUARD CHEST PERCUSSOR, Substantially Equivalent on 1985-12-03. Applicant: Cas Medical Systems, Inc..

Clearance details

Applicant: Cas Medical Systems, Inc.
Product code: Code BYI
Advisory panel: Anesthesiology
Date received: 1985-09-26
Decision date: 1985-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

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Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.