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OPTI MEDICAL SYSTEMS INC.

Matched from indexed company URL: Opti Medical Systems, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041024033004102403OPTI MEDICAL SYSTEMS INC.1N2026-01-01235 Hembree Park Dr ROSWELL GA US 30076

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
258321607980875K993837AVL OPTI CRITICAL CARE ANALYZERCGA1999-12-16
258321457448724K984299AVL OPTI CRITICAL CARE ANALYZERJFP1998-12-11
258321520610452K974822AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROLJJY1998-01-22
258321553339058K974784AVL OPTI CRITICAL CARE ANALYZERCEM1998-02-24
258321678398625K880710PROTEIN BASE ISE CONTROLJJR1988-03-24
258321525847857K131126OPTI CCA-TS2CHL2013-08-22
258321265933770K093280OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561CHL2011-01-07
258321547175297K070371FINGERTIP PULSE OXIMETER MD300CDQA2007-08-13
258321927813635K061730OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044CEM2006-08-04
258321689963870K052027OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200CGZ2005-09-29
258321477234262K001632OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009JJY2000-06-19
258321915145600
258321977591114

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CHL22013-08-22
CEM22006-08-04
JJY22000-06-19
DQA12007-08-13
CGZ12005-09-29
CGA11999-12-16
JFP11998-12-11
JJR11988-03-24

PMN#

GUDID#