ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS— 510(k) K920364

Name: FDA 510(k) clearance K920364
Creator: U.S. Food and Drug Administration
Published: 1992-03-17

Substantially Equivalent

Biosound, Inc.

FDA 510(k) clearance K920364 for ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS, Substantially Equivalent on 1992-03-17. Applicant: Biosound, Inc.. Device class: 2.

Clearance details

Applicant: Biosound, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1992-01-28
Decision date: 1992-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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 Biosound, Inc.

view all

K971700 — BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER1997-07-09
K963936 — ACCESSPOINT, MED E-MAIL, DICOM READER1997-03-31
K963262 — ARTOSCAN M1997-03-28
K963662 — GALILEO EVOKED POTENTIALRE1997-02-26
K953716 — INTRACAVITY TRANSDUCERS1996-04-17

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.