Cleared Traditional

CONDENSATE COLLECTION KIT

K954480 · Nova-Ventrx · Anesthesiology
Dec 1995
Decision
94d
Days
Class 1
Risk

About This 510(k) Submission

K954480 is an FDA 510(k) clearance for the CONDENSATE COLLECTION KIT, a Circuit, Breathing (w Connector, Adaptor, Y Piece) (Class I — General Controls, product code CAI), submitted by Nova-Ventrx (Northbrook, US). The FDA issued a Cleared decision on December 29, 1995, 94 days after receiving the submission on September 26, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5240.

Submission Details

510(k) Number K954480 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1995
Decision Date December 29, 1995
Days to Decision 94 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAI — Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5240

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