INFANT APNEA MONITOR— 510(k) K802710

Name: FDA 510(k) clearance K802710
Creator: U.S. Food and Drug Administration
Published: 1980-11-12

Substantially Equivalent

Douglas Scientific Products

FDA 510(k) clearance K802710 for INFANT APNEA MONITOR, Substantially Equivalent on 1980-11-12. Applicant: Douglas Scientific Products. Device class: 2.

Clearance details

Applicant: Douglas Scientific Products
Product code: Code FLS
Device class: Class 2
Regulation: 21 CFR 868.2377
Advisory panel: Anesthesiology
Date received: 1980-10-31
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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