GGM Breathing Circuit Bacterial Filter— 510(k) K210352

Substantially Equivalent

Great Group Medical Co, Ltd.

FDA 510(k) clearance K210352 for GGM Breathing Circuit Bacterial Filter, Substantially Equivalent on 2022-03-27. Applicant: Great Group Medical Co, Ltd..

Clearance details

Applicant
Great Group Medical Co, Ltd.
Product code
Code CAH
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chaughua County, TW
Download summary PDFView on FDA.gov ↗

Adverse events under product code CAH

product code CAH
Death
7
Total
7

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.