VENTIMETER VENTILATOR— 510(k) K790733

Substantially Equivalent

Narco Air-Shields

FDA 510(k) clearance K790733 for VENTIMETER VENTILATOR, Substantially Equivalent on 1979-04-19. Applicant: Narco Air-Shields.

Clearance details

Applicant
Narco Air-Shields
Product code
Code CBK
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 CBK

product code CBK
Death
736
Injury
3,628
Malfunction
98,786
Other
4
Total
103,154

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.