MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215— 510(k) K033614

Substantially Equivalent

Northgate Technologies, Inc.

FDA 510(k) clearance K033614 for MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215, Substantially Equivalent on 2004-07-29. Applicant: Northgate Technologies, Inc..

Clearance details

Applicant: Northgate Technologies, Inc.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2003-11-17
Decision date: 2004-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elgin, IL, US

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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, 2020-01-01 through 2026-04-23. 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.