CAPNO-FLO— 510(k) K933626

Substantially Equivalent

Kirk Specialty Systems

FDA 510(k) clearance K933626 for CAPNO-FLO, Substantially Equivalent on 1993-10-06. Applicant: Kirk Specialty Systems.

Clearance details

Applicant
Kirk Specialty Systems
Product code
Code BTM
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carrollton, TX, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code BTM

product code BTM
Death
19
Other
2
Total
21

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.