CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING— 510(k) K112768

Substantially Equivalent

Calypso 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..

Clearance details

Applicant: Calypso Medical Technologies, Inc.
Product code: Code LHN
Advisory panel: Radiology
Date received: 2011-09-22
Decision date: 2011-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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