RESPIRATORY CARE MONITOR— 510(k) K812977

Name: FDA 510(k) clearance K812977
Creator: U.S. Food and Drug Administration
Published: 1981-11-16

Substantially Equivalent

Advanced Medical Equipment, Inc.

FDA 510(k) clearance K812977 for RESPIRATORY CARE MONITOR, Substantially Equivalent on 1981-11-16. Applicant: Advanced Medical Equipment, Inc.. Device class: 1.

Clearance details

Applicant: Advanced Medical Equipment, Inc.
Product code: Code BZA
Device class: Class 1
Regulation: 21 CFR 868.5810
Advisory panel: Anesthesiology
Date received: 1981-10-23
Decision date: 1981-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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