MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION— 510(k) K991786

Name: FDA 510(k) clearance K991786
Creator: U.S. Food and Drug Administration
Published: 1999-11-18

Substantially Equivalent

General Electric Medical Systems Information Techn

FDA 510(k) clearance K991786 for MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION, Substantially Equivalent on 1999-11-18. Applicant: General Electric Medical Systems Information Techn. Device class: 2.

Clearance details

Applicant: General Electric Medical Systems Information Techn
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1999-05-25
Decision date: 1999-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, 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 General Electric Medical Systems Information Techn

view all

K023380 — T-WAVE ALTERMANS (TWA) ALGORITHM OPTION2002-12-03
K021470 — SEER LIGHT COMPACT DIGITAL HOLTER RECORDER2002-11-14
K023100 — ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS2002-10-11
K021454 — UNITY NETWORK ID2002-10-01
K020290 — DASH 3000/4000 PATIENT MONITOR2002-08-14

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.