V2— 510(k) K970481

Name: FDA 510(k) clearance K970481
Creator: U.S. Food and Drug Administration
Published: 1997-07-01

Substantially Equivalent - Subject to Tracking Reg.

Survivalink Corp.

FDA 510(k) clearance K970481 for V2, Substantially Equivalent - Subject to Tracking Reg. on 1997-07-01. Applicant: Survivalink Corp.. Device class: 2.

Clearance details

Applicant: Survivalink Corp.
Product code: Code LDD
Device class: Class 2
Regulation: 21 CFR 870.5300
Advisory panel: Cardiovascular
Date received: 1997-02-10
Decision date: 1997-07-01
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.