TRACHEA/CUFF INFLATOR W/PRESSURE #583— 510(k) K831577

Name: FDA 510(k) clearance K831577
Creator: U.S. Food and Drug Administration
Published: 1983-07-07

Substantially Equivalent

Medical Electronics Corp.

FDA 510(k) clearance K831577 for TRACHEA/CUFF INFLATOR W/PRESSURE #583, Substantially Equivalent on 1983-07-07. Applicant: Medical Electronics Corp.. Device class: 2.

Clearance details

Applicant: Medical Electronics Corp.
Product code: Code BSK
Device class: Class 2
Regulation: 21 CFR 868.5750
Advisory panel: Anesthesiology
Date received: 1983-05-17
Decision date: 1983-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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