FDA.reportPublic FDA data

Vyaire Medical GmbH.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96151021000271197Vyaire Medical GmbH.1N2020-04-25LEIBNIZSTRASSE 7 HOECHBERG Bayern DE 97204

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2006741261569922K992214OXYCON PROBZC2000-02-22
2006741894330904K972419TOENNIES NEUROSCREEN SYSTEMIKN1998-04-30
2006741480595052K965042MICRODL DIARYCARD SPIROMETERBZG1997-06-17
2006741766623769K963035MICRO SPIROMETERBZG1996-11-01
2006741096211880K950197MICROCOCCJ1996-10-17
2006741986652416K940375MICRO MPMCAP1994-11-21
2006741217302663K936108MASTERSCREEN BODYJEH1995-02-03
2006741828747658K933839MASTER SCREEN PNUEMOBTY1994-03-07
2006741070438854K853434ERGO-PNEUMOTESTBZL1986-02-05
2006741420738971K853360N20 TESTCBR1985-09-03
2006741502042160K843855ERGOTEST 40 & 45ISP1984-11-27
2006741502635012K843850UNIVERSAL-ERGOTESTISD1984-11-27
2006741128192151K843847O2 TESTCCL1984-10-12
2006741147143892K843845CO TESTCCJ1984-10-12
2006741259273535K843844CO2 TESTCCK1984-10-12
2006741395163454K843843HE TESTBSE1984-12-04
2006742071037946K843840N2 TEST1984-10-12
2006741214150929K190853Vyntus BODYBZC2019-08-16
2006741790083645K183567Vyntus/SentrySuite Product LineBZC2019-08-23
2006741708486191K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CARTBZC2018-11-30
2006741606961869K153654Sentry WEB SmartInterpDQK2016-09-16
2006741855010868K150810Vyntus / SentrySuite Product LineBZC2015-08-14
2006741687693288K142959Vyntus WalkDQA2015-03-20
2006741953292889K141936MICROBLAB, MICROLOOPBZG2014-12-29
2006741833978197K133925VYNTUS/ SENTRYSUITE PRODUCT LINEBZC2014-08-22
2006741529837625K122699SENTRYSUITE PRODUCT LINEBTY2012-11-19
2006741736222801K113813SENTRYSUITE PRODUCT LINEBTY2012-05-10
2006741421633658K113096MICRO IBZG2012-04-13
2006741524560999K111408MICROGARD IICAH2011-10-17
2006741923008194K111053SENTRYSUITE PRODUCT LINEBTY2011-08-12
2006741794733757K101873MASTERSCREEN IOSBZG2011-02-10
2006741178042123K100928MICRO DIARY SPIROMETERBZG2011-03-07
2006741992778720K081823MASTERSCREEN PAED - BABY BODYCCM2009-05-18
2006741272413481K080510VIP PULMONARY FUNCTION SYSTEMBTY2008-08-20
2006741088714755K072323MASTERSCREEN & OXYCON CPXBZC2007-10-10
2006741560052877K072061MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODYJEH2008-04-22
2006741745682434K071753MASTERSCREEN PNEUMO & MASTERSCOPEBTY2007-08-14
2006741815123193K061283PULMOLIFEBZG2006-12-14
2006741089339904K040698MASTERSCREEN CPX AND OXYCON CPXBZC2004-04-07
2006741746515081K031194SPIROSOFTBTY2003-07-30
2006741308638808K031102MICROLAB SPIROMETERBZG2003-12-01
2006741959510025K030586MICROPEAKBZH2003-08-27
2006741576103680K023796MS PAED-BABY BODYCCM2003-03-03
2006741701628071K023120OXYCON MOBILEBZC2003-11-12
2006741904402628K021138SLEEPSCREEN/APNOESCREEN CARDIOMNR2003-02-12
2006741277590526K001502AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PROBZC2000-07-12
2006741575713428K000396APNOESCREEN PRO, ALPHA SCREEN PROMNR2000-12-27
2006741446596110
2006741573525271
2006741792442135
2006741847707101

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZC102019-08-23
BZG82014-12-29
BTY72012-11-19
CCM22009-05-18
JEH22008-04-22
MNR22003-02-12
CCJ21996-10-17
DQK12016-09-16
DQA12015-03-20
CAH12011-10-17
BZH12003-08-27
IKN11998-04-30
CAP11994-11-21
BZL11986-02-05
CBR11985-09-03
BSE11984-12-04
ISD11984-11-27
ISP11984-11-27
CCL11984-10-12
CCK11984-10-12