BCI 3403 SLEEP SCREENING PULSE OXIMETER— 510(k) K011156

Substantially Equivalent

Bci, Inc.

FDA 510(k) clearance K011156 for BCI 3403 SLEEP SCREENING PULSE OXIMETER, Substantially Equivalent on 2001-06-14. Applicant: Bci, Inc..

Clearance details

Applicant: Bci, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2001-04-16
Decision date: 2001-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.