DeviceClearance

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.. Device class: Unclassified.

Clearance details

Applicant
Aubrey, Inc.
Product code
Code KGN
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KGN

product code KGN
Other
2
Total
2

Source: openFDA MAUDE database, through . 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.