510(k) Report

Devices descending from K921048

102 later devices reach BP8800T/8000IR/8300G Non-Invasive Blood Pres. Syst through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+9K223721Masimo StorkMasimo Corporation20230—