INFORMED REMOTE FIELD UNIT MODEL IFM1000— 510(k) K821712

Name: FDA 510(k) clearance K821712
Creator: U.S. Food and Drug Administration
Published: 1982-07-26

Substantially Equivalent

Burditt & Calkins-Siemens-Elema

FDA 510(k) clearance K821712 for INFORMED REMOTE FIELD UNIT MODEL IFM1000, Substantially Equivalent on 1982-07-26. Applicant: Burditt & Calkins-Siemens-Elema. Device class: 2.

Clearance details

Applicant: Burditt & Calkins-Siemens-Elema
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 1982-06-09
Decision date: 1982-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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