FDA 510(k) Premarket Notification K082979: S8 ADVANCE

Submission Details & Decision

Normalized public record details for 510(k) notification K082979.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K082979

Applicant / Sponsor

Resmed, Ltd.

Device Name

S8 ADVANCE

Product Code

BZD

Decision Date

2009-01-02

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Anesthesiology (AN)

Clearance Type

Traditional

Third Party Flag

Date Received

2008-10-06

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