K112768
Substantially EquivalentCALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
- Applicant
- Calypso Medical Technologies, Inc.
- Product code
- LHN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.