APNEA ALARM FOR ADULT-PEDIATRIC & NEON— 510(k) K831601

Name: FDA 510(k) clearance K831601
Creator: U.S. Food and Drug Administration
Published: 1983-09-26

Substantially Equivalent

Plasmedics, Inc.

FDA 510(k) clearance K831601 for APNEA ALARM FOR ADULT-PEDIATRIC & NEON, Substantially Equivalent on 1983-09-26. Applicant: Plasmedics, Inc.. Device class: 2.

Clearance details

Applicant: Plasmedics, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1983-05-18
Decision date: 1983-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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