MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR— 510(k) K864261

Name: FDA 510(k) clearance K864261
Creator: U.S. Food and Drug Administration
Published: 1987-03-27

Substantially Equivalent

Bio-Dyne, Inc.

FDA 510(k) clearance K864261 for MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR, Substantially Equivalent on 1987-03-27. Applicant: Bio-Dyne, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Dyne, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1986-10-29
Decision date: 1987-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, CT, US

Download summary PDF View on FDA.gov ↗

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