CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING— 510(k) K112768
Substantially EquivalentCalypso Medical Technologies, Inc.
FDA 510(k) clearance K112768 for CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING, Substantially Equivalent on 2011-11-18. Applicant: Calypso Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Calypso Medical Technologies, Inc.
- Product code
- Code LHN
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
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