EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS— 510(k) K913395

Name: FDA 510(k) clearance K913395
Creator: U.S. Food and Drug Administration
Published: 1992-05-20

Substantially Equivalent

Pro-Tech, Inc.

FDA 510(k) clearance K913395 for EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS, Substantially Equivalent on 1992-05-20. Applicant: Pro-Tech, Inc.. Device class: 2.

Clearance details

Applicant: Pro-Tech, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 1991-07-30
Decision date: 1992-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodinville, WA, US

Download summary PDF View on FDA.gov ↗

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