Plexus— 510(k) K191107

Substantially Equivalent

Alleva Medical (D.G), Ltd.

FDA 510(k) clearance K191107 for Plexus, Substantially Equivalent on 2019-08-27. Applicant: Alleva Medical (D.G), Ltd.. Device class: 2.

Clearance details

Applicant
Alleva Medical (D.G), Ltd.
Product code
Code JOW
Device class
Class 2
Regulation
21 CFR 870.5800
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shek Mun, HK
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