FDA.reportPublic FDA data

EVENT MEDICAL, LTD.

Matched from indexed company URL: Event Medical, Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30061359413006135941EVENT MEDICAL, LTD.1N2026-01-0160 Empire Dr Lake Forest CA US 92630

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860008873606eVolution 3e Ventilator - eVolution 3e Ventilator System19499001917a.hedayati@event-medical.com
00860008873637INSPIRATION 7i Ventilator - "INSPIRATION 7i Ventilator System, 17"" screen "949-900-1917a.hedayati@event-medical.com
B079EVL100500T1EVOLUTION - T9499001917Customer.Service@event-medical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
214711401797188K130178INSPIRATION VENTILATOR SYSTEM 5I/7ICBK2013-10-29
214711158092585K113743EVOLUTION 3E VENTILATORCBK2012-12-18
214711822965038K072590INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEMCBK2008-01-04
214711296717200K051550INSPIRATION VENTILATOR SYSTEMCBK2005-07-12
214711421886684K030341MODIFICATION TO INSPIRATION VENTILATOR SYSTEMCBK2004-01-16
214711553640395K021112INSPIRATION VENTILATOR SYSTEMCBK2002-11-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CBK82013-10-29

PMN#

GUDID#