FDA 510(k) Premarket Notification K182075: BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)

Submission Details & Decision

Normalized public record details for 510(k) notification K182075.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K182075

Applicant / Sponsor

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Device Name

BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)

Product Code

MHX

Decision Date

2018-12-10

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2018-08-01

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