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Alias Born 11/14/2017

Re: None

Wednesday, 11/29/2017 9:54:42 AM

Wednesday, November 29, 2017 9:54:42 AM

Post# of 12427
All aprovals in process! HEARTSENTRY is an FDA regulated product that uses the expedited 510(k)
premarket approval process
HeartSentry FDA Classification:
• Class: II
• Panel: Cardiovascular
Likely HeartSentry Predicates
• Itamar Medical EndoPat 2000
• iHealth Wireless Blood Pressure Monitor
International market approvals are also being pursued.