PANASONIC TELE-HOMECARE SYSTEM— 510(k) K004050

Name: FDA 510(k) clearance K004050
Creator: U.S. Food and Drug Administration
Published: 2001-03-15

Substantially Equivalent

Matsushita Electric Industrial Co., Ltd.

FDA 510(k) clearance K004050 for PANASONIC TELE-HOMECARE SYSTEM, Substantially Equivalent on 2001-03-15. Applicant: Matsushita Electric Industrial Co., Ltd.. Device class: 2.

Clearance details

Applicant: Matsushita Electric Industrial Co., Ltd.
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2000-12-29
Decision date: 2001-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MWI

view all

K260438 — Vital Signs Monitor (CLEO2)2026-08-14
K253417 — Masimo Root Monitoring System2026-08-12
K253196 — Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)2026-06-12
K253436 — c-med0 alpha2026-04-30
K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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 →

Recalls naming K004050

K-number listed on FDA's recall record

Z-0822-2013 — Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.Class II·Terminated·Viterion TeleHealthcare Llc·20121115

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K004050.

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