KUNG SHIN, HMEF SK203
FDA 510(k) clearance K032878 · decided 2004-09-20
Clearance details
- K-number
- K032878
- Device name
- KUNG SHIN, HMEF SK203
- Applicant
- Kung Shin Plastics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-15
- Decision date
- 2004-09-20
- Days to decision
- 371 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Hsin Chu City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filte recall (Z-1268-2025) | Kung Shin Plastics Co. Ltd. | 2025-03-04 |
| CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056) recall (Z-1269-2025) | Kung Shin Plastics Co. Ltd. | 2025-03-04 |