CAPNO-FLO REGULATOR, CAPNO-FLO— 510(k) K952512

Substantially Equivalent

Kirk Specialty Systems

FDA 510(k) clearance K952512 for CAPNO-FLO REGULATOR, CAPNO-FLO, Substantially Equivalent on 1995-08-28. Applicant: Kirk Specialty Systems. Device class: 2.

Clearance details

Applicant
Kirk Specialty Systems
Product code
Code BTM
Device class
Class 2
Regulation
21 CFR 868.5915
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carrollton, TX, US
Download summary PDFView on FDA.gov ↗

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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.