K102314

Substantially Equivalent

3M INTEGRATED CYCLER (110V) & (220V)

Applicant: Focus Diagnostics, Inc.
Product code: OOI
Advisory panel: Clinical Chemistry
Date received: 2010-08-16
Decision date: 2010-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Adverse events under product code OOI

product code OOI

Malfunction: 2,506
Other: 3
Total: 2,509

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.