510(k) K210352
K210352 is an FDA 510(k) premarket notification submitted by Great Group Medical Co, Ltd. for the device "GGM Breathing Circuit Bacterial Filter". The FDA issued a decision of Substantially Equivalent on March 27, 2022. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2022
- Date Received
- February 8, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Bacterial, Breathing-Circuit
- Device Class
- Class II
- Regulation Number
- 868.5260
- Review Panel
- HO
- Submission Type