9100 MUTIGAS MONITOR— 510(k) K941971

Substantially Equivalent

Bci Intl., Inc.

FDA 510(k) clearance K941971 for 9100 MUTIGAS MONITOR, Substantially Equivalent on 1994-11-21. Applicant: Bci Intl., Inc..

Clearance details

Applicant: Bci Intl., Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1994-04-22
Decision date: 1994-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.