TRACOE smart Cuff Manager— 510(k) K152865
Substantially EquivalentTracoe Medical GmbH
FDA 510(k) clearance K152865 for TRACOE smart Cuff Manager, Substantially Equivalent on 2016-09-27. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nieder-Olm, DE
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Data sourced from openFDA. This site is unofficial and independent of the FDA.