70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER— 510(k) K091185

Clearance details

Applicant

Hsiner Co., Ltd.

Product code

Code CAH

Device class

Class 2

Regulation

21 CFR 868.5260

Advisory panel

Anesthesiology

Date received

2009-04-23

Decision date

2009-07-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Temecula, CA, US

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Death

7

Total

7

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 →