Cleared Traditional

PRESSURE MONITOR, MODEL 1131B

K801110 · American Optical Corp. · Cardiovascular
May 1980
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K801110 is an FDA 510(k) clearance for the PRESSURE MONITOR, MODEL 1131B, a Computer, Blood-pressure (Class II — Special Controls, product code DSK), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1980, 8 days after receiving the submission on May 12, 1980. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1110.

Submission Details

510(k) Number K801110 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1980
Decision Date May 20, 1980
Days to Decision 8 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DSK — Computer, Blood-pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1110

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