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

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..

Clearance details

Applicant: Hsiner Co., Ltd.
Product code: Code CBK
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 ↗

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.