CARDIORATER CR-3— 510(k) K812145

Name: FDA 510(k) clearance K812145
Creator: U.S. Food and Drug Administration
Published: 1981-09-25

Substantially Equivalent

Life Science Instrumentation, Inc.

FDA 510(k) clearance K812145 for CARDIORATER CR-3, Substantially Equivalent on 1981-09-25. Applicant: Life Science Instrumentation, Inc.. Device class: 2.

Clearance details

Applicant: Life Science Instrumentation, Inc.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1981-07-28
Decision date: 1981-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Life Science Instrumentation, Inc.

view all

K850812 — EMERGIPACE - EXTERNAL PACEMAKER1985-11-05
K842037 — LS 51985-03-01
K843396 — LS-260G MONITOR/RECORDER & DEFIBILLATOR1984-10-19
K840246 — MINI-DEFIBRILLATOR 280/41984-04-17
K822617 — VPD540 DEFIBRILLATOR1983-04-28

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.