MODEL 500E INFANT MONITORING SYSTEM— 510(k) K873791

Name: FDA 510(k) clearance K873791
Creator: U.S. Food and Drug Administration
Published: 1987-11-23

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K873791 for MODEL 500E INFANT MONITORING SYSTEM, Substantially Equivalent on 1987-11-23. Applicant: Ge Medical Systems Information Technologies. Device class: 2.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1987-09-17
Decision date: 1987-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

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