FDA 510(k) Premarket Notification K810593: NEUROPAC ULTRA I

Submission Details & Decision

Normalized public record details for 510(k) notification K810593.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K810593

Applicant / Sponsor

Medical Devices, Inc.

Device Name

NEUROPAC ULTRA I

Product Code

GZJ

Decision Date

1981-03-13

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Neurology (NE)

Clearance Type

Traditional

Third Party Flag

Date Received

1981-03-05

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