VIVAPORE 2— 510(k) K943966

Substantially Equivalent

Vivascience, Inc.

FDA 510(k) clearance K943966 for VIVAPORE 2, Substantially Equivalent on 1995-04-11. Applicant: Vivascience, Inc.. Device class: 1.

Clearance details

Applicant: Vivascience, Inc.
Product code: Code JJH
Device class: Class 1
Regulation: 21 CFR 862.2310
Advisory panel: Clinical Chemistry
Date received: 1994-07-28
Decision date: 1995-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

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