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

Name: FDA 510(k) clearance K102373
Creator: U.S. Food and Drug Administration
Published: 2010-09-30

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.. 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: 2010-08-20
Decision date: 2010-09-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.