HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER— 510(k) K950004

Name: FDA 510(k) clearance K950004
Creator: U.S. Food and Drug Administration
Published: 1995-10-24

Substantially Equivalent

Aerotel, Ltd.

FDA 510(k) clearance K950004 for HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER, Substantially Equivalent on 1995-10-24. Applicant: Aerotel, Ltd.. Device class: 2.

Clearance details

Applicant: Aerotel, Ltd.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1995-01-03
Decision date: 1995-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPS

view all

K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)2026-07-02
K251670 — MAC 7 Resting ECG Analysis System2026-01-26
K252361 — AccurECG Analysis System (v2.0)2025-12-22
K252474 — Withings BeamO (SCT02)2025-11-10
K250569 — Cardiologs Holter Platform2025-08-06

More clearances from Aerotel, Ltd.

view all

K980144 — HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER1998-06-16
K953762 — HEART 400 ECG TRANSMITTER1996-07-18
K961362 — AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE1996-07-10
K931020 — HEART 10011995-01-11
K930314 — HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE1994-03-18

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.