RESPIRATION & HEART RATE MONITOR 530— 510(k) K843681

Name: FDA 510(k) clearance K843681
Creator: U.S. Food and Drug Administration
Published: 1984-12-04

Substantially Equivalent

Tri-Med, Inc.

FDA 510(k) clearance K843681 for RESPIRATION & HEART RATE MONITOR 530, Substantially Equivalent on 1984-12-04. Applicant: Tri-Med, Inc.. Device class: 2.

Clearance details

Applicant: Tri-Med, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1984-09-18
Decision date: 1984-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.