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FDA 510(k)

ITP, MODEL 1.0

K-Number: K992434 · 2000-01-13

ApplicantNucletron Corp.
Decision Date2000-01-13
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ITP, MODEL 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corp.. It received FDA 510(k) clearance on 2000-01-13 under 510(k) number K992434. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ITP, MODEL 1.0?

ITP, MODEL 1.0 is a medical device that received FDA 510(k) clearance on 2000-01-13. The listed applicant is Nucletron Corp.. The 510(k) number is K992434.

When did ITP, MODEL 1.0 receive FDA 510(k) clearance?

ITP, MODEL 1.0 received FDA 510(k) clearance on 2000-01-13, under 510(k) number K992434.

Who is the listed applicant for ITP, MODEL 1.0?

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

What is the FDA product code for ITP, MODEL 1.0?

The FDA product code for ITP, MODEL 1.0 is MUJ.

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Other records listing Nucletron Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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