Search Results
Found 2 results
510(k) Data Aggregation
K Number
K060382Device Name
FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1
Manufacturer
Date Cleared
2006-04-19
(64 days)
Product Code
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
AMERIFLO CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Flo-Rite Conserving Device Regulator is intended for prescription use only, to be used in conjunction with a portable oxygen tank for supplemental oxygen therapy for in home or ambulatory application.
Device Description
Flo-Rite, Flo-Rite II, Nuematix, Simpulse and Simpulse II.
Ask a Question
Ask a specific question about this device
K Number
K041057Device Name
FLO-RITE
Manufacturer
Date Cleared
2004-08-12
(111 days)
Product Code
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
AMERIFLO CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Flo-Rite Conserving Device Regulator is intended for prescription use only, to be used in conjunction with a portable oxygen tank for supplemental oxygen therapy for in-home or ambulatory application.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1