Cleared Traditional

K895779 - MODIFIED PERMCATH TRAY (2ND SUBMISSION)
(FDA 510(k) Clearance)

K895779 · Quinton, Inc. · Anesthesiology
Dec 1989
Decision
91d
Days
Class 2
Risk

K895779 is an FDA 510(k) clearance for the MODIFIED PERMCATH TRAY (2ND SUBMISSION), a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on December 7, 1989, 91 days after receiving the submission on September 7, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K895779 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 1989
Decision Date December 07, 1989
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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