MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE— 510(k) K854734

Name: FDA 510(k) clearance K854734
Creator: U.S. Food and Drug Administration
Published: 1986-02-10

Substantially Equivalent

Medasonics, Inc.

FDA 510(k) clearance K854734 for MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE, Substantially Equivalent on 1986-02-10. Applicant: Medasonics, Inc.. Device class: 2.

Clearance details

Applicant: Medasonics, Inc.
Product code: Code DRM
Device class: Class 2
Regulation: 21 CFR 870.5200
Advisory panel: Cardiovascular
Date received: 1985-11-25
Decision date: 1986-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRM

view all

K221700 — AutoPulse NXT Resuscitation System2023-03-09
K211289 — RMU-2000 Automated Chest Compression System2021-11-09
K173553 — LUCAS 3 Chest Compression System2018-02-08
K161768 — LUCAS 3 Chest Compression System2016-11-09
K153628 — ROSC-U Mini Chest Compressor (RMCC)2016-01-30

More clearances from Medasonics, Inc.

view all

K991441 — CADENCE DOPPLER ULTRASOUND SYSTEM1999-12-28
K962796 — NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM1997-01-21
K961116 — FIRST BEAT/CARDIO BEAT/CALC1996-08-08
K914862 — CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS1992-12-03
K911453 — OBTRASOUND STETHOSCOPE FETAL CALC1991-06-20

Adverse events under product code DRM

product code DRM

Death: 82
Injury: 126
Malfunction: 4,539
Total: 4,747

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.