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FDA 510(k)

PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)

K-Number: K963124 · 1996-11-08

ApplicantFisma, Inc.
Decision Date1996-11-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PC LASER WITH SMART PLUG (PC EDO & DENTAL 200) is the device name listed in this FDA 510(k) record. The listed applicant is Fisma, Inc.. It received FDA 510(k) clearance on 1996-11-08 under 510(k) number K963124. 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 PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)?

PC LASER WITH SMART PLUG (PC EDO & DENTAL 200) is a medical device that received FDA 510(k) clearance on 1996-11-08. The listed applicant is Fisma, Inc.. The 510(k) number is K963124.

When did PC LASER WITH SMART PLUG (PC EDO & DENTAL 200) receive FDA 510(k) clearance?

PC LASER WITH SMART PLUG (PC EDO & DENTAL 200) received FDA 510(k) clearance on 1996-11-08, under 510(k) number K963124.

Who is the listed applicant for PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)?

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 PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)?

The FDA product code for PC LASER WITH SMART PLUG (PC EDO & DENTAL 200) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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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.

K000158VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9K991464DENTAL 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-IV

Related Devices (Code: GEX)

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

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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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