FDA 510(k) Premarket Notification K991012: SIEMENS INFINITY EEG POD

Submission Details & Decision

Normalized public record details for 510(k) notification K991012.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K991012

Applicant / Sponsor

Siemens Medical Solutions USA, Inc.

Device Name

SIEMENS INFINITY EEG POD

Product Code

OLT

Decision Date

1999-06-24

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Neurology (NE)

Clearance Type

Traditional

Third Party Flag

Date Received

1999-03-26

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