510(k) Report

Devices descending from K980719

2 later devices reach CALM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102263Horizon Perinatal Care Surveillance and Archival Model Verson 4.0Mckesson Information Solutions, LLC20110—
+1K052715Calm Curve, Version 01.00Lms Medical Systems (Canada), Ltd.20050—