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FDA 510(k)

SKELTEX ISV

K-Number: K091234 · 2010-02-16

ApplicantSkeltex Technologies, Inc.
Decision Date2010-02-16
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SKELTEX ISV is the device name listed in this FDA 510(k) record. The listed applicant is Skeltex Technologies, Inc.. It received FDA 510(k) clearance on 2010-02-16 under 510(k) number K091234. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKELTEX ISV?

SKELTEX ISV is a medical device that received FDA 510(k) clearance on 2010-02-16. The listed applicant is Skeltex Technologies, Inc.. The 510(k) number is K091234.

When did SKELTEX ISV receive FDA 510(k) clearance?

SKELTEX ISV received FDA 510(k) clearance on 2010-02-16, under 510(k) number K091234.

Who is the listed applicant for SKELTEX ISV?

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

What is the FDA product code for SKELTEX ISV?

The FDA product code for SKELTEX ISV is NDN.

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Official Source

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

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