510(k) K032878 ยท CAH Filter, Bacterial, Breathing-Circuit
KUNG SHIN, HMEF SK203
| Applicant | Kung Shin Plastics Co., Ltd., Hsin Chu City, TW |
| Decision | Substantially Equivalent, Sep 20, 2004 |
| Received | Sep 15, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032878
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2025 | Kung Shin Plastics Co. Ltd. CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126) Open, Classified |
CAH | None listed |
| Mar 4, 2025 | Kung Shin Plastics Co. Ltd. CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056) Open, Classified |
CAH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.