FDA 510(k) Premarket Notification K972301: BIG BEN SQUARE, BIG BEN ROUND

Submission Details & Decision

Normalized public record details for 510(k) notification K972301.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K972301

Applicant / Sponsor

Rudolf Riester GmbH & Co. KG

Device Name

BIG BEN SQUARE, BIG BEN ROUND

Product Code

DXQ

Decision Date

1997-09-17

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

1997-06-19

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