POLYSONIC ULTRASOUND LOTION— 510(k) K827296

Name: FDA 510(k) clearance K827296
Creator: U.S. Food and Drug Administration
Published: 1982-04-16

Substantially Equivalent

Parker Laboratories, Inc.

FDA 510(k) clearance K827296 for POLYSONIC ULTRASOUND LOTION, Substantially Equivalent on 1982-04-16. Applicant: Parker Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Parker Laboratories, Inc.
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 1982-03-30
Decision date: 1982-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUI

view all

K253255 — Non-Sterile Ultrasound Gel Sterile Ultrasound Gel2026-06-17
K252337 — EdgeFlow Gel Pad2026-04-24
K242167 — Sterile and Non-Sterile Ultrasonic Coupling Agent2024-09-19
K241789 — Non-Sterile Ultrasound Transmission Gels2024-07-24
K232957 — Sterile and Non-Sterile Ultrasound Gels2023-12-15

More clearances from Parker Laboratories, Inc.

view all

K233965 — UltraDrape UGPIV Barrier and Securement (34-15)2024-08-15
K953673 — ECLIPSE PROBE COVER1996-03-14
K921695 — ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS1995-02-23
K864556 — AQUALUBE(TM)1986-12-01
K861239 — ACRYLIC SOLDER1986-04-17

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