GUIDELINES FOR PEDIATRIC ANESTHESIA— 510(k) K842610

Substantially Equivalent

Critical Care Micro Computing

FDA 510(k) clearance K842610 for GUIDELINES FOR PEDIATRIC ANESTHESIA, Substantially Equivalent on 1984-10-04. Applicant: Critical Care Micro Computing.

Clearance details

Applicant
Critical Care Micro Computing
Product code
Code CAC
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 CAC

product code CAC
Death
11
Malfunction
477
Total
488

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.