VENTRONICS #5590 ECII OXYGEN MONITOR— 510(k) K812854

Substantially Equivalent

Ventronics, Div of Hudson Oxygen Therapy Sales Co.

FDA 510(k) clearance K812854 for VENTRONICS #5590 ECII OXYGEN MONITOR, Substantially Equivalent on 1981-11-06. Applicant: Ventronics, Div of Hudson Oxygen Therapy Sales Co..

Clearance details

Applicant
Ventronics, Div of Hudson Oxygen Therapy Sales Co.
Product code
Code CCL
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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.