SYSTEM I INFANT MONITORING SYS— 510(k) K820943

Name: FDA 510(k) clearance K820943
Creator: U.S. Food and Drug Administration
Published: 1982-05-03

Substantially Equivalent

Burr Engineering & Development Co.

FDA 510(k) clearance K820943 for SYSTEM I INFANT MONITORING SYS, Substantially Equivalent on 1982-05-03. Applicant: Burr Engineering & Development Co.. Device class: 2.

Clearance details

Applicant: Burr Engineering & Development Co.
Product code: Code FLS
Device class: Class 2
Regulation: 21 CFR 868.2377
Advisory panel: Anesthesiology
Date received: 1982-04-06
Decision date: 1982-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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