DeviceClearance

FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER— 510(k) K970866

Substantially Equivalent

Georgia Biomedical, Inc.

FDA 510(k) clearance K970866 for FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER, Substantially Equivalent on 1998-01-23. Applicant: Georgia Biomedical, Inc.. Device class: 2.

Clearance details

Applicant
Georgia Biomedical, Inc.
Product code
Code HIF
Device class
Class 2
Regulation
21 CFR 884.1730
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Attleboro, MA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code HIF

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Adverse events under product code HIF

product code HIF
Death
19
Injury
578
Malfunction
5,639
Total
6,236

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.