NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202— 510(k) K102120

Name: FDA 510(k) clearance K102120
Creator: U.S. Food and Drug Administration
Published: 2011-08-12

Substantially Equivalent

Hsiner Co., Ltd.

FDA 510(k) clearance K102120 for NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202, Substantially Equivalent on 2011-08-12. Applicant: Hsiner Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hsiner Co., Ltd.
Product code: Code CBK
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2010-07-29
Decision date: 2011-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.