Cleared Traditional

RESPIRATORY SENSOR

K811014 · Impact Instrumentation, Inc. · Anesthesiology
Jun 1981
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K811014 is an FDA 510(k) clearance for the RESPIRATORY SENSOR, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Impact Instrumentation, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1981, 48 days after receiving the submission on April 15, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K811014 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1981
Decision Date June 02, 1981
Days to Decision 48 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BZQ — Monitor, Breathing Frequency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375

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