Harga Harga retail pleth Premarket fda

penawaran e-katalog notif 510 (k)

Mindray 11.880.000 9.782.593 + +
P60 (SB 6.500.000)
Promed 450.000 + -
Fingertip
Promed 3.000.000 + -
handheld
PM1-mini
Nonin 22.000.000 38.500.000 - +
Avant 9600
Nonin 36.000.000 48.065.446 - +
Avant 2120
Beurer PO 875.000 + -
30
Elitech 3.630.000 + -
FOX-3
Nellcor 30.800.000 + +
PM10N
Nonin Onyx 4.680.000 - (+)
Vantage (225$/
9590 3.185.651)
Nonin Onyx - +
II 9550

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=1&
Center=&Panel=&ProductCode=&KNumber=&Applicant=&DeviceName=pulse%20o
ximeter&Type=&ThirdPartyReviewed=&ClinicalTrials=&Decision=&DecisionDateFro
m=&DecisionDateTo=04%2F03%2F2019&IVDProducts=&Redact510K=&Combinati
onProducts=&ZNumber=&PAGENUM=500&sortcolumn=an_asc
oximetri regulation
https://www.fda.gov/RegulatoryInformation/Guidances/ucm341718.htm
ISO 80601-2-61:2017 https://www.iso.org/standard/67963.html