AWBAT-S, AWBAT-D, AWBAT-M— 510(k) K082869

Substantially Equivalent

Aubrey, Inc.

FDA 510(k) clearance K082869 for AWBAT-S, AWBAT-D, AWBAT-M, Substantially Equivalent on 2009-02-06. Applicant: Aubrey, Inc..

Clearance details

Applicant: Aubrey, Inc.
Product code: Code KGN
Advisory panel: Unknown
Date received: 2008-09-29
Decision date: 2009-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

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.