Cleared Traditional

K880683 - KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT
(FDA 510(k) Clearance)

K880683 · King Systems Corp. · Anesthesiology
Mar 1988
Decision
19d
Days
Class 1
Risk

K880683 is an FDA 510(k) clearance for the KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT, a Circuit, Breathing (w Connector, Adaptor, Y Piece) (Class I — General Controls, product code CAI), submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on March 9, 1988, 19 days after receiving the submission on February 19, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5240.

Submission Details

510(k) Number K880683 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1988
Decision Date March 09, 1988
Days to Decision 19 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

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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