BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A— 510(k) K001770

Substantially Equivalent

Bci, Inc.

FDA 510(k) clearance K001770 for BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A, Substantially Equivalent on 2000-07-05. Applicant: Bci, Inc..

Clearance details

Applicant: Bci, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2000-06-12
Decision date: 2000-07-05
Decision: Substantially Equivalent
Clearance type: Special
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.