PORTABLE OPERAT. RM. MONITORS HS30/40— 510(k) K832356

Name: FDA 510(k) clearance K832356
Creator: U.S. Food and Drug Administration
Published: 1983-10-28

Substantially Equivalent

Medtel Pty. , Ltd.

FDA 510(k) clearance K832356 for PORTABLE OPERAT. RM. MONITORS HS30/40, Substantially Equivalent on 1983-10-28. Applicant: Medtel Pty. , Ltd.. Device class: 1.

Clearance details

Applicant: Medtel Pty. , Ltd.
Product code: Code BZN
Device class: Class 1
Regulation: 21 CFR 868.6175
Advisory panel: Anesthesiology
Date received: 1983-07-18
Decision date: 1983-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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