BLY-501 ADAPTOR— 510(k) K012540

Name: FDA 510(k) clearance K012540
Creator: U.S. Food and Drug Administration
Published: 2001-09-26

Substantially Equivalent

Micromedical Industries, Ltd.

FDA 510(k) clearance K012540 for BLY-501 ADAPTOR, Substantially Equivalent on 2001-09-26. Applicant: Micromedical Industries, Ltd.. Device class: 2.

Clearance details

Applicant: Micromedical Industries, Ltd.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2001-08-07
Decision date: 2001-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Labrador, Queensland, AU

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 Micromedical Industries, Ltd.

view all

K013311 — MODIFICATION TO: POCKETVIEW ECG SOFTWARE2002-01-03
K990266 — MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE1999-02-02
K922528 — CMS SYSTEM1995-05-12
K915624 — MODIFIED BIOLOG1992-03-27
K915627 — PACEVIEW1992-03-27

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.