BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1— 510(k) K991831

Name: FDA 510(k) clearance K991831
Creator: U.S. Food and Drug Administration
Published: 1999-06-11

Substantially Equivalent

Boston Medical Technologies, Inc.

FDA 510(k) clearance K991831 for BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1, Substantially Equivalent on 1999-06-11. Applicant: Boston Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Boston Medical Technologies, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1999-05-28
Decision date: 1999-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wakefield, MA, 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 Boston Medical Technologies, Inc.

view all

K010955 — BMT ANSCORE HEALTH MANAGEMENT SYSTEM2001-04-26
K993875 — BMT ANSCORE HEALTH MANAGEMENT SYSTEM2000-08-11

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.