PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF— 510(k) K810751

Name: FDA 510(k) clearance K810751
Creator: U.S. Food and Drug Administration
Published: 1981-04-10

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K810751 for PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF, Substantially Equivalent on 1981-04-10. Applicant: General Electric Co.. Device class: 2.

Clearance details

Applicant: General Electric Co.
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 1981-03-20
Decision date: 1981-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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