Cleared Traditional

VIVAPORE 2

K943966 · Vivascience, Inc. · Chemistry
Apr 1995
Decision
257d
Days
Class 1
Risk

About This 510(k) Submission

K943966 is an FDA 510(k) clearance for the VIVAPORE 2, a Clinical Sample Concentrator (Class I — General Controls, product code JJH), submitted by Vivascience, Inc. (Acton, US). The FDA issued a Cleared decision on April 11, 1995, 257 days after receiving the submission on July 28, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2310.

Submission Details

510(k) Number K943966 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1994
Decision Date April 11, 1995
Days to Decision 257 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJH — Clinical Sample Concentrator
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2310