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FDA 510(k)

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

K-Number: K040208 · 2004-05-11

ApplicantTz Medical, Inc.
Decision Date2004-05-11
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND is the device name listed in this FDA 510(k) record. The listed applicant is Tz Medical, Inc.. It received FDA 510(k) clearance on 2004-05-11 under 510(k) number K040208. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND?

NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND is a medical device that received FDA 510(k) clearance on 2004-05-11. The listed applicant is Tz Medical, Inc.. The 510(k) number is K040208.

When did NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND receive FDA 510(k) clearance?

NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND received FDA 510(k) clearance on 2004-05-11, under 510(k) number K040208.

Who is the listed applicant for NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND?

The FDA 510(k) record lists Tz Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND?

The FDA product code for NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND is QSY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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