510(k) Report

Devices descending from K111200

8 later devices reach Mac-Lab System, Cardiolab System, Combolab System, Specialslab System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130626Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System…Ge Medical Systems Information Technologies, Inc.201371
+2K213972Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording…Ge Healthcare Information Technologies, Inc.202211
+2K180805Pure EPBiosig Technologies20180—
+2K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV20171—
+2K152864Merge HemoMerge Healthcare Incorporated201612
+3K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV20250—
+3K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client…Ge Medical Systems Information Technologies, Inc.20240—
+3K233326Merge Hemo, Model RCSV2Merge Healthcare Incorporated202401