MODEL 535 NEO-TRAK RECORDER— 510(k) K855045

Name: FDA 510(k) clearance K855045
Creator: U.S. Food and Drug Administration
Published: 1986-05-16

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K855045 for MODEL 535 NEO-TRAK RECORDER, Substantially Equivalent on 1986-05-16. Applicant: Ge Medical Systems Information Technologies. Device class: 1.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code DSF
Device class: Class 1
Regulation: 21 CFR 870.2810
Advisory panel: Cardiovascular
Date received: 1985-12-17
Decision date: 1986-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

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