MR FIBER OPTIC ECG GATING SYSTEM— 510(k) K031731

Name: FDA 510(k) clearance K031731
Creator: U.S. Food and Drug Administration
Published: 2003-07-30

Substantially Equivalent

Sa Instruments, Inc.

FDA 510(k) clearance K031731 for MR FIBER OPTIC ECG GATING SYSTEM, Substantially Equivalent on 2003-07-30. Applicant: Sa Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Sa Instruments, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2003-06-04
Decision date: 2003-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stony Brook, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.