Cleared Traditional

MODULAR MASS SPECTROMETER (M.S.)

K862605 · The Perkin-Elmer Corp. · Anesthesiology
Aug 1986
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K862605 is an FDA 510(k) clearance for the MODULAR MASS SPECTROMETER (M.S.), a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by The Perkin-Elmer Corp. (Pomona, US). The FDA issued a Cleared decision on August 13, 1986, 36 days after receiving the submission on July 8, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K862605 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1986
Decision Date August 13, 1986
Days to Decision 36 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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