CALYPSO SYSTEM WITH DYNAMIC EDGE GATING— 510(k) K102373

Substantially Equivalent

Calypso Medical Technologies, Inc.

FDA 510(k) clearance K102373 for CALYPSO SYSTEM WITH DYNAMIC EDGE GATING, Substantially Equivalent on 2010-09-30. Applicant: Calypso Medical Technologies, Inc..

Clearance details

Applicant: Calypso Medical Technologies, Inc.
Product code: Code LHN
Advisory panel: Radiology
Date received: 2010-08-20
Decision date: 2010-09-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Seattle, WA, US

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