PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR— 510(k) K871344

Name: FDA 510(k) clearance K871344
Creator: U.S. Food and Drug Administration
Published: 1987-10-20

Substantially Equivalent

Reynolds Medical , Ltd.

FDA 510(k) clearance K871344 for PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR, Substantially Equivalent on 1987-10-20. Applicant: Reynolds Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Reynolds Medical , Ltd.
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1987-04-06
Decision date: 1987-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herts Sg14 1hz, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Reynolds Medical , Ltd.

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K024283 — CARDIODIRECT, MODELS 12M, 12I, 12S2003-08-01
K013367 — CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH2001-12-13
K011345 — CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM2001-07-20
K011837 — LIFECARD CF 7 DAY2001-07-13
K001025 — LIFECARD CF COMPACT RECORDER2000-04-19

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.