K210352 is an FDA 510(k) clearance for the GGM Breathing Circuit Bacterial Filter. This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Great Group Medical Co, Ltd. (Chaughua County, TW). The FDA issued a Cleared decision on March 27, 2022, 412 days after receiving the submission on February 8, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K210352 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2021 |
| Decision Date | March 27, 2022 |
| Days to Decision | 412 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | CAH - Filter, Bacterial, Breathing-circuit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5260 |