FDA 510(k)

APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4

K-Number: K033001 · 2003-12-24

Decision Date2003-12-24

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4 is the device name listed in this FDA 510(k) record. The listed applicant is Transphoton Corporation. It received FDA 510(k) clearance on 2003-12-24 under 510(k) number K033001. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4?

APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4 is a medical device that received FDA 510(k) clearance on 2003-12-24. The listed applicant is Transphoton Corporation. The 510(k) number is K033001.

When did APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4 receive FDA 510(k) clearance?

APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4 received FDA 510(k) clearance on 2003-12-24, under 510(k) number K033001.

Who is the listed applicant for APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4?

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

What is the FDA product code for APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4?

The FDA product code for APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4 is KPS.

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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.