510(k) Report

Devices descending from K040194

13 later devices reach Compumedics Summit IP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093223Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited20101—
+1K043132Universal XacttraceMedcare Flaga200410—
+2K230073OktiCompumedics Limited20230—
+2K173793XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems20191—
+2K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+3K242424Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc.20240—
+3K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+3K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+3K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+4K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+4K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+5K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+6K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—