DBT, DYNAMIC BUBBLE TRAP— 510(k) K031323

Substantially Equivalent

Convergenza AG

FDA 510(k) clearance K031323 for DBT, DYNAMIC BUBBLE TRAP, Substantially Equivalent on 2003-08-01. Applicant: Convergenza AG. Device class: 2.

Clearance details

Applicant: Convergenza AG
Product code: Product code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 2003-04-25
Decision date: 2003-08-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

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