Cleared Traditional

SPECTRA CENTRAL PT MONITORING SYS

K792081 · American Optical Corp. · Cardiovascular
Nov 1979
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K792081 is an FDA 510(k) clearance for the SPECTRA CENTRAL PT MONITORING SYS, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979, 28 days after receiving the submission on October 16, 1979. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K792081 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1979
Decision Date November 13, 1979
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DSI — Detector And Alarm, Arrhythmia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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