Cleared Traditional

PRIMA, INC. ADULT ANESTHESIA CIRCUIT

K944533 · Prima, Inc. · Anesthesiology
Nov 1994
Decision
75d
Days
Class 1
Risk

About This 510(k) Submission

K944533 is an FDA 510(k) clearance for the PRIMA, INC. ADULT ANESTHESIA CIRCUIT, a Circuit, Breathing (w Connector, Adaptor, Y Piece) (Class I — General Controls, product code CAI), submitted by Prima, Inc. (Cleveland, US). The FDA issued a Cleared decision on November 29, 1994, 75 days after receiving the submission on September 15, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5240.

Submission Details

510(k) Number K944533 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1994
Decision Date November 29, 1994
Days to Decision 75 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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