DeviceClearance

HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.— 510(k) K894918

Substantially Equivalent

Mennen Medical, Inc.

FDA 510(k) clearance K894918 for HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP., Substantially Equivalent on 1989-10-31. Applicant: Mennen Medical, Inc.. Device class: 2.

Clearance details

Applicant
Mennen Medical, Inc.
Product code
Code CCL
Device class
Class 2
Regulation
21 CFR 868.1720
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Clarence, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CCL

product code CCL
Other
2
Total
2

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.