HSH/H512 ADULT PHYSIOLOGICAL MONITORS— 510(k) K791838

Name: FDA 510(k) clearance K791838
Creator: U.S. Food and Drug Administration
Published: 1979-10-01

Substantially Equivalent

Medtel Pty. , Ltd.

FDA 510(k) clearance K791838 for HSH/H512 ADULT PHYSIOLOGICAL MONITORS, Substantially Equivalent on 1979-10-01. Applicant: Medtel Pty. , Ltd.. Device class: 2.

Clearance details

Applicant: Medtel Pty. , Ltd.
Product code: Code DSK
Device class: Class 2
Regulation: 21 CFR 870.1110
Advisory panel: Cardiovascular
Date received: 1979-09-14
Decision date: 1979-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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