MODEL 525 NEO-TRAK NEONATAL RECORDER— 510(k) K823210

Name: FDA 510(k) clearance K823210
Creator: U.S. Food and Drug Administration
Published: 1982-11-24

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K823210 for MODEL 525 NEO-TRAK NEONATAL RECORDER, Substantially Equivalent on 1982-11-24. 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: 1982-10-28
Decision date: 1982-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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