FDA.reportPublic FDA data

Andrea Mitchell

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
97101073003348376Andrea Mitchell1N2020-04-2515 Hampshire Street Mansfield MA US 02048
30130600983013060098Andrea Mitchell1N2020-04-2515 Hampshire Street Mansfield MA US 02048

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2279521585438302K994428E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODEGEI2000-03-07
196741828465456K183453VS3-IROWN2019-03-04
196741785570522K180171PillCam Patency SystemNSI2018-03-08
196742015284065K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0NEZ2017-09-01
196741930085055K153466PillCam COLON 2 Capsule Endoscopy SystemPGD2016-01-14
196741382335130K152204VS3-IR systemOWN2015-10-28
196741911061517K151086ManoScan SystemFFX2016-04-28
196741381257998K150018VS3-IR-MMS SystemOWN2015-06-17
196741340148336K140284GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEMNEZ2014-12-17
196741370077878K123864GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEMNEZ2013-08-12
196741274445864K102543BRAVO PH MONITORING SYSTEM AND ACCESSORIESFFT2010-12-01
196741712219708K092342SMARTPILL GI MONITORING SYSTEM, VERSION 2.0NYV2009-10-30
196741250935506

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OWN32019-03-04
NEZ32017-09-01
NSI12018-03-08
FFX12016-04-28
PGD12016-01-14
FFT12010-12-01
NYV12009-10-30
GEI12000-03-07