Cleared Traditional

KING SYSTEMS, BREATHING BAG

K880680 · King Systems Corp. · Anesthesiology
Mar 1988
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K880680 is an FDA 510(k) clearance for the KING SYSTEMS, BREATHING BAG, a Bag, Reservoir (Class I — General Controls, product code BTC), submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on March 3, 1988, 13 days after receiving the submission on February 19, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5320.

Submission Details

510(k) Number K880680 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1988
Decision Date March 03, 1988
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BTC — Bag, Reservoir
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5320

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