FDA 510(k) Premarket Notification K203126: S10 Kirra

Submission Details & Decision

Normalized public record details for 510(k) notification K203126.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K203126

Applicant / Sponsor

Resmed Pty , Ltd.

Device Name

S10 Kirra

Product Code

BZD

Decision Date

2020-12-18

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Anesthesiology (AN)

Clearance Type

Traditional

Third Party Flag

Date Received

2020-10-19

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