V2— 510(k) K970481
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..
Clearance details
- Applicant
- Survivalink Corp.
- Product code
- Code LDD
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Minnetonka, MN, US
Adverse events under product code LDD
product code LDD- Death
- 38
- Malfunction
- 522
- Total
- 560
Source: openFDA MAUDE database, through . 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.