FDA.reportPublic FDA data

Christine Gerbutavich

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30106059583010605958Christine Gerbutavich1N2020-04-25135 Beaver Street Suite 207 North Waltham MA US 02452

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1643981617677396K163429B6OXO2017-01-04
1643981918969984K160343SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic ScannerIYN2016-04-07
1643981938656361K151280MultiScan G-Arm SystemOXO2015-09-30
1643981657863908K141672DIGIARC 100AU+OXO2014-07-31
1643981441449798K131423G-ARM MULTISCAN SYSTEMOXO2013-11-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OXO42017-01-04
IYN12016-04-07