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FDA 510(k)

VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9

K-Number: K000158 · 2000-08-24

ApplicantFisma, Inc.
Decision Date2000-08-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 is the device name listed in this FDA 510(k) record. The listed applicant is Fisma, Inc.. It received FDA 510(k) clearance on 2000-08-24 under 510(k) number K000158. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9?

VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 is a medical device that received FDA 510(k) clearance on 2000-08-24. The listed applicant is Fisma, Inc.. The 510(k) number is K000158.

When did VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 receive FDA 510(k) clearance?

VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 received FDA 510(k) clearance on 2000-08-24, under 510(k) number K000158.

Who is the listed applicant for VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9?

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

What is the FDA product code for VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9?

The FDA product code for VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 is GEX. This falls under the Gastroenterology category.

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Other records listing Fisma, Inc. 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.

K991464DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50K990174ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IVK963124PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)

Related Devices (Code: GEX)

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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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