IntelliVue Capnography Extension, IntelliVue Microstream Extension— 510(k) K172904

Substantially Equivalent

Philips Medizin Systeme Boeblingen GmbH

FDA 510(k) clearance K172904 for IntelliVue Capnography Extension, IntelliVue Microstream Extension, Substantially Equivalent on 2017-12-26. Applicant: Philips Medizin Systeme Boeblingen GmbH.

Clearance details

Applicant
Philips Medizin Systeme Boeblingen GmbH
Product code
Code CCK
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boeblingen, DE
Download summary PDFView on FDA.gov ↗

Adverse events under product code CCK

product code CCK
Death
3
Malfunction
11,428
Total
11,431

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.