510(k) Report

Devices descending from K031643

44 later devices reach Spirotel, Model 29-1020 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103575Spiro PDPmd Healthcare20110—
+1K043528SpirotelMir Medical Intl. Research Srl200542—
+2K130784SpirotelMir Medical Intl. Research Srl20130—
+2K061712Spirobank IIMir Medical Intl. Research Srl200640—
+3K103530SpirodocMedical International Research USA, Inc.20114—
+3K081033MiroxiMir Medical Intl. Research Srl20090—
+3K072979Spirobank GMir Medical Intl. Research Srl200733—
+4K231416Air Next (NVD-02)Nuvoair AB20240—
+4K230501Spirobank OxiMir Medical International Research USA20230—
+4K201002Safey Pocket SpirometerSafey Medical Devices Pvt, Ltd.20200—
+4K183089Air NextNuvoair AB20201—
+4K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+4K170798Dictum HealthDictum Health, Inc.20175—
+4K163249GoSpiroMonitored Therapeutics, Inc.20172—
+4K141546Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd.20142—
+4K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+5K241397HinscopeHinlab Sas20240—
+5K222525Alveoair Digital SpirometerRoundworks Technologies Private Limited20230—
+5K213754SpiroHome Personal, SpiroHome ClinicInofab Saglik Teknolojileri A.S20230—
+5K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+5K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+5K222550Current Health SystemCurrent Health, Ltd.20221—
+5K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+5K202837GoSpiroMonitored Therapeutics, Inc.20200—
+5K201562SpirotracVitalograph Ireland, Ltd.20200—
+5K190561NICU V'02Cosmed Nordic Aps20200—
+5K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+5K142642Vitalograph Model 6600 CompactVitalograph (Ireland), Ltd.20150—
+5K102047Lci Option for InnocorInnovision A/S201101
+6K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+6K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+6K232915EpiMonitorEmpatica S.r.l.20241—
+6K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+6K231506Current Health SystemCurrent Health, Ltd.20230—
+6K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+7K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+7K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+7K252981EmbraceMiniEmpatica S.r.l.20251—
+7K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+7K250515EpiMonitorEmpatica S.r.l.20250—
+7K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+7K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+7K240901StethophoneSparrow Acoustics, Inc.20241—
+8K252595Stethophone ProSparrow Acoustics, Inc.20250—