FDA 510(k) Premarket Notification K040208: NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND

Submission Details & Decision

Normalized public record details for 510(k) notification K040208.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K040208

Applicant / Sponsor

Tz Medical, Inc.

Device Name

NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND

Product Code

QSY

Decision Date

2004-05-11

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Unknown ()

Clearance Type

Traditional

Third Party Flag

Date Received

2004-01-30

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