INFANT MONITOR 16900— 510(k) K843546

Substantially Equivalent

Healthdyne, Inc.

FDA 510(k) clearance K843546 for INFANT MONITOR 16900, Substantially Equivalent on 1984-10-10. Applicant: Healthdyne, Inc.. Device class: 2.

Clearance details

Applicant: Healthdyne, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1984-09-10
Decision date: 1984-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, 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.