FDA 510(k) Premarket Notification K974588: INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD

Submission Details & Decision

Normalized public record details for 510(k) notification K974588.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K974588

Applicant / Sponsor

Rimed , Ltd.

Device Name

INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD

Product Code

IYN

Decision Date

1998-08-07

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Traditional

Third Party Flag

Date Received

1997-12-09

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