HTS 220 CARDIAC MONITOR— 510(k) K884524

Name: FDA 510(k) clearance K884524
Creator: U.S. Food and Drug Administration
Published: 1989-04-10

Substantially Equivalent

Life Sensing Instrument Company, Inc.

FDA 510(k) clearance K884524 for HTS 220 CARDIAC MONITOR, Substantially Equivalent on 1989-04-10. Applicant: Life Sensing Instrument Company, Inc.. Device class: 2.

Clearance details

Applicant: Life Sensing Instrument Company, Inc.
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1988-10-27
Decision date: 1989-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tullahoma, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSI

view all

K243349 — BodyGuardian Remote Monitoring System (BGRMS v3.0)2026-01-23
K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)2025-07-29
K240177 — Zio AT® device (A100A1001)2024-10-30
K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System2023-10-06
K231276 — SmartCardia 7L Platform2023-08-30

More clearances from Life Sensing Instrument Company, Inc.

view all

K960884 — TELE TRENS TM 101997-09-12
K931136 — APOLLO CAMERA1994-01-11
K896967 — HTS 820 CARDIAC MONITOR1990-03-19
K861067 — PARAGON 420, CARDIAC MONITOR1986-06-05

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.