FIDELITY 200 CARDIAC EVENT RECORDER— 510(k) K071228
Substantially EquivalentSignalife, Inc.
FDA 510(k) clearance K071228 for FIDELITY 200 CARDIAC EVENT RECORDER, Substantially Equivalent on 2007-11-21. Applicant: Signalife, Inc..
Clearance details
- Applicant
- Signalife, Inc.
- Product code
- Code DXH
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Greenville, SC, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.