약학회지

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Table. 5.

Comparison between 510k medical device and De Novo medical device12,13)

510k De Novo
Predicate device ×
Risk and effectiveness be found in the approval document of predicate device must be proved by applicant
Risk class 2 2
Approval process Only 510k submission (1) 510k decline
(2) Direct De Novo
Approval code form KXXZZZZ DENXXZZZZ
Example reSET-O® (K173681) reSET® (DEN160018)

reSET® is predicate device of reSET-O®.

XX=year of submission (e.g., 17=2017)

ZZZZ=submission increments from 0001

Yakhak Hoeji 2023;67:67-74 https://doi.org/10.17480/psk.2023.67.2.67
© 2023 Yakhak Hoeji