510(k) K210352

GGM Breathing Circuit Bacterial Filter by Great Group Medical Co, Ltd. — Product Code CAH

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