FDA-Device2025-03-12Class II
Philips IntelliSpace Cardiovascular software, Model 830089.
Philips Medical Systems Nederland B.V.
Hazard
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Sold states
US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA, IN, KY, MA, MI, MN, NC, NE, NY, OH, OR, TN, TX, VA, and WI. There was government distribution but no military distribution.
Affected count
139
Manufactured in
High Tech Campus 36, Eindhoven, Netherlands
Products
Philips IntelliSpace Cardiovascular software, Model 830089.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1252-2025Don't want to check this manually?
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