TRACOE Cuff Pressure Monitor— 510(k) K152778

Name: FDA 510(k) clearance K152778
Creator: U.S. Food and Drug Administration
Published: 2016-12-21

Substantially Equivalent

Tracoe Medical GmbH

FDA 510(k) clearance K152778 for TRACOE Cuff Pressure Monitor, Substantially Equivalent on 2016-12-21. Applicant: Tracoe Medical GmbH. Device class: 2.

Clearance details

Applicant: Tracoe Medical GmbH
Product code: Code BSK
Device class: Class 2
Regulation: 21 CFR 868.5750
Advisory panel: Anesthesiology
Date received: 2015-09-25
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nieder-Olm, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.