#6010 NON-CONDUCTIVE VENTILATOR CIRCUIT— 510(k) K852314

Substantially Equivalent

Sigma Medical, Inc.

FDA 510(k) clearance K852314 for #6010 NON-CONDUCTIVE VENTILATOR CIRCUIT, Substantially Equivalent on 1985-08-13. Applicant: Sigma Medical, Inc..

Clearance details

Applicant: Sigma Medical, Inc.
Product code: Code CAI
Advisory panel: Anesthesiology
Date received: 1985-05-29
Decision date: 1985-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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Adverse events under product code CAI

product code CAI

Malfunction: 869
Other: 1
Total: 870

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.