TREND PROCESSOR OPTION FOR #515 NEONAT— 510(k) K833552

Name: FDA 510(k) clearance K833552
Creator: U.S. Food and Drug Administration
Published: 1984-01-27

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K833552 for TREND PROCESSOR OPTION FOR #515 NEONAT, Substantially Equivalent on 1984-01-27. Applicant: Ge Medical Systems Information Technologies. Device class: 2.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1983-10-14
Decision date: 1984-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRT

view all

K261286 — The Circadia C300 System (C300)2026-05-20
K252676 — The Circadia C300 System (C300)2026-02-03
K253388 — Sleepiz One+ (Model 2.5)2026-01-28
K251364 — Sleepiz One+ (2.5)2025-07-29
K234003 — The Circadia C200 System2024-05-30

More clearances from Ge Medical Systems Information Technologies

view all

K120770 — QT GUARD PLUS ANALYSIS SYSTEM2012-12-06
K102426 — CARESCAPE MODEL V100 VITAL SIGNS MONITOR2010-10-20
K092369 — 12SL ECG ANALYSIS PROGRAM2010-02-24
K093141 — MARS HOLTER ANALYSIS WORKSTATION2009-12-29
K092027 — CARESCAPE MONITOR B8502009-08-28

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.