ACCUSONIC PLUS, MODEL AP-100— 510(k) K001370

Name: FDA 510(k) clearance K001370
Creator: U.S. Food and Drug Administration
Published: 2000-07-17

Substantially Equivalent

Metron Medical Australia, Pty, Ltd.

FDA 510(k) clearance K001370 for ACCUSONIC PLUS, MODEL AP-100, Substantially Equivalent on 2000-07-17. Applicant: Metron Medical Australia, Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Metron Medical Australia, Pty, Ltd.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2000-05-01
Decision date: 2000-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrum Downs, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code IMI

view all

K240788 — Ultrasound Stimulator2025-06-04
K230472 — Sonopuls 1902023-10-24
K222098 — ManaSport+2023-03-08
K210284 — ManaSport2022-04-26
K202788 — Sonomed IV, Sonomed V2021-12-23

More clearances from Metron Medical Australia, Pty, Ltd.

view all

K132137 — MULTISTIM2013-09-12
K124010 — ACCUSONIC ADVANTAGE2013-08-23
K120171 — ACCUSONIC ADVANTAGE2012-05-04
K030880 — VECTORSONIC, MODEL VU-2702003-04-18
K030648 — VECTORSURGE 5 MODEL 4702003-03-28

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