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FDA 510(k)

TRIPTER X-1 COMPACT DUET

K-Number: K023535 · 2003-01-17

ApplicantDirex Systems Corp.
Decision Date2003-01-17
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRIPTER X-1 COMPACT DUET is the device name listed in this FDA 510(k) record. The listed applicant is Direx Systems Corp.. It received FDA 510(k) clearance on 2003-01-17 under 510(k) number K023535. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIPTER X-1 COMPACT DUET?

TRIPTER X-1 COMPACT DUET is a medical device that received FDA 510(k) clearance on 2003-01-17. The listed applicant is Direx Systems Corp.. The 510(k) number is K023535.

When did TRIPTER X-1 COMPACT DUET receive FDA 510(k) clearance?

TRIPTER X-1 COMPACT DUET received FDA 510(k) clearance on 2003-01-17, under 510(k) number K023535.

Who is the listed applicant for TRIPTER X-1 COMPACT DUET?

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

What is the FDA product code for TRIPTER X-1 COMPACT DUET?

The FDA product code for TRIPTER X-1 COMPACT DUET is LNS.

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Other records listing Direx Systems Corp. as applicant

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Related Devices (Code: LNS)

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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