ULTRASOUND GEL— 510(k) K850290

Name: FDA 510(k) clearance K850290
Creator: U.S. Food and Drug Administration
Published: 1985-04-18

Substantially Equivalent

Litton Datamedix

FDA 510(k) clearance K850290 for ULTRASOUND GEL, Substantially Equivalent on 1985-04-18. Applicant: Litton Datamedix. Device class: 2.

Clearance details

Applicant: Litton Datamedix
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1985-01-24
Decision date: 1985-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sharon, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYO

view all

K253452 — Accuro 3S2026-07-24
K260190 — ARTHUR2026-06-18
K252237 — EdgeFlow UW202026-04-17
K254021 — Accuro XV2026-04-09
K253898 — QT Scanner 2000 Model A2026-03-04

More clearances from Litton Datamedix

view all

K853599 — LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI1986-03-21
K842497 — SERVOMED OXYMONITO SMK 3631984-10-04
K842235 — SERVOCARD DEFIBRILLATOR SCP-8511984-08-27
K842312 — SERVOCARD SCP-8401984-08-27

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.