Cleared Traditional

K832767 - ADVANTAGE #1700
(FDA 510(k) Clearance)

K832767 · The Perkin-Elmer Corp. · Anesthesiology
Nov 1983
Decision
79d
Days
Class 2
Risk

K832767 is an FDA 510(k) clearance for the ADVANTAGE #1700, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1983, 79 days after receiving the submission on August 16, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K832767 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 1983
Decision Date November 03, 1983
Days to Decision 79 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1400

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