CAIRD TECHNOLOGY HOLTER 2000— 510(k) K012686

Name: FDA 510(k) clearance K012686
Creator: U.S. Food and Drug Administration
Published: 2001-12-13

Substantially Equivalent

Caird Technology

FDA 510(k) clearance K012686 for CAIRD TECHNOLOGY HOLTER 2000, Substantially Equivalent on 2001-12-13. Applicant: Caird Technology. Device class: 2.

Clearance details

Applicant: Caird Technology
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2001-08-14
Decision date: 2001-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, SC, 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 Caird Technology

view all

K101016 — ANS SYSTEM2011-01-28
K971336 — CAIRD TECHNOLOGY SPIROMETER1998-12-01

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.