PCI MODEL 2041-PC TELEMETRY MONITOR— 510(k) K901031

Name: FDA 510(k) clearance K901031
Creator: U.S. Food and Drug Administration
Published: 1990-05-17

Substantially Equivalent

Accucore, Inc.

FDA 510(k) clearance K901031 for PCI MODEL 2041-PC TELEMETRY MONITOR, Substantially Equivalent on 1990-05-17. Applicant: Accucore, Inc.. Device class: 2.

Clearance details

Applicant: Accucore, Inc.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1990-03-06
Decision date: 1990-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRT

view all

K261286 — The Circadia C300 System (C300)2026-05-20
K252676 — The Circadia C300 System (C300)2026-02-03
K253388 — Sleepiz One+ (Model 2.5)2026-01-28
K251364 — Sleepiz One+ (2.5)2025-07-29
K234003 — The Circadia C200 System2024-05-30

More clearances from Accucore, Inc.

view all

K942147 — PACIFIC COMMUNICATIONS MODEL 11001995-01-30
K925411 — MODEL 2041-PC/ST CARDIAC TELEMETRY MONITOR1993-02-25
K913576 — DATASCOPE MODEL VISA CENTRAL MONITOR1992-01-28
K913400 — MODEL SCR-10001991-08-21
K896775 — PCI MODEL 2041-B TELEMETRY MONITOR1990-05-17

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.