510(k) Report

Devices descending from K043528

42 later devices reach Spirotel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130784SpirotelMir Medical Intl. Research Srl20130—
+1K061712Spirobank IIMir Medical Intl. Research Srl200640—
+2K103530SpirodocMedical International Research USA, Inc.20114—
+2K081033MiroxiMir Medical Intl. Research Srl20090—
+2K072979Spirobank GMir Medical Intl. Research Srl200733—
+3K231416Air Next (NVD-02)Nuvoair AB20240—
+3K230501Spirobank OxiMir Medical International Research USA20230—
+3K201002Safey Pocket SpirometerSafey Medical Devices Pvt, Ltd.20200—
+3K183089Air NextNuvoair AB20201—
+3K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+3K170798Dictum HealthDictum Health, Inc.20175—
+3K163249GoSpiroMonitored Therapeutics, Inc.20172—
+3K141546Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd.20142—
+3K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+4K241397HinscopeHinlab Sas20240—
+4K222525Alveoair Digital SpirometerRoundworks Technologies Private Limited20230—
+4K213754SpiroHome Personal, SpiroHome ClinicInofab Saglik Teknolojileri A.S20230—
+4K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+4K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+4K222550Current Health SystemCurrent Health, Ltd.20221—
+4K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+4K202837GoSpiroMonitored Therapeutics, Inc.20200—
+4K201562SpirotracVitalograph Ireland, Ltd.20200—
+4K190561NICU V'02Cosmed Nordic Aps20200—
+4K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+4K142642Vitalograph Model 6600 CompactVitalograph (Ireland), Ltd.20150—
+4K102047Lci Option for InnocorInnovision A/S201101
+5K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+5K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+5K232915EpiMonitorEmpatica S.r.l.20241—
+5K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+5K231506Current Health SystemCurrent Health, Ltd.20230—
+5K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+6K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+6K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+6K252981EmbraceMiniEmpatica S.r.l.20251—
+6K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+6K250515EpiMonitorEmpatica S.r.l.20250—
+6K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+6K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+6K240901StethophoneSparrow Acoustics, Inc.20241—
+7K252595Stethophone ProSparrow Acoustics, Inc.20250—