ECG & ULTRASOUND GELS, CREAMS & LOTION— 510(k) K803151

Name: FDA 510(k) clearance K803151
Creator: U.S. Food and Drug Administration
Published: 1980-12-30

Substantially Equivalent

Abco Dealers, Inc.

FDA 510(k) clearance K803151 for ECG & ULTRASOUND GELS, CREAMS & LOTION, Substantially Equivalent on 1980-12-30. Applicant: Abco Dealers, Inc.. Device class: 2.

Clearance details

Applicant: Abco Dealers, Inc.
Product code: Code GYB
Device class: Class 2
Regulation: 21 CFR 882.1275
Advisory panel: Neurology
Date received: 1980-12-12
Decision date: 1980-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GYB

view all

K243749 — Jmoon Conductive Gel2025-04-08
K220735 — Avologi Gel Primer (Model: Av25)2023-09-15
K222770 — Conductive Gel2022-12-13
K221724 — Conductive Gel2022-09-23
K212325 — EEG-acp2022-06-15

More clearances from Abco Dealers, Inc.

view all

K905025 — DIGITAL THERMOMETER KITS1991-02-07
K882304 — DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)1988-07-12
K880892 — BLOOD COLLECTING NEEDLE AND HOLDERS1988-04-21
K880894 — ALLERGIST SYRINGES1988-03-31
K872875 — STRETCH GAUZE BANDAGES1987-09-04

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