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FDA 510(k)

KILTEX PROBE COVER

K-Number: K961029 · 1996-07-25

ApplicantKiltex Corp.
Decision Date1996-07-25
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KILTEX PROBE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Kiltex Corp.. It received FDA 510(k) clearance on 1996-07-25 under 510(k) number K961029. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KILTEX PROBE COVER?

KILTEX PROBE COVER is a medical device that received FDA 510(k) clearance on 1996-07-25. The listed applicant is Kiltex Corp.. The 510(k) number is K961029.

When did KILTEX PROBE COVER receive FDA 510(k) clearance?

KILTEX PROBE COVER received FDA 510(k) clearance on 1996-07-25, under 510(k) number K961029.

Who is the listed applicant for KILTEX PROBE COVER?

The FDA 510(k) record lists Kiltex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KILTEX PROBE COVER?

The FDA product code for KILTEX PROBE COVER is IYO.

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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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