FDA 510(k) Premarket Notification K030317: MODEL 1300GE-64: PEDIATRIC POSITIONER

Submission Details & Decision

Normalized public record details for 510(k) notification K030317.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K030317

Applicant / Sponsor

Midwest Rf, LLC

Device Name

MODEL 1300GE-64: PEDIATRIC POSITIONER

Product Code

MOS

Decision Date

2003-03-25

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Traditional

Third Party Flag

Date Received

2003-01-30

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