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FDA 510(k)

XENON 300MX

K-Number: K980044 · 1998-04-03

ApplicantPerkinelmer Optoelectronics
Decision Date1998-04-03
Product CodeFSS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XENON 300MX is the device name listed in this FDA 510(k) record. The listed applicant is Perkinelmer Optoelectronics. It received FDA 510(k) clearance on 1998-04-03 under 510(k) number K980044. The device is classified under product code FSS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XENON 300MX?

XENON 300MX is a medical device that received FDA 510(k) clearance on 1998-04-03. The listed applicant is Perkinelmer Optoelectronics. The 510(k) number is K980044.

When did XENON 300MX receive FDA 510(k) clearance?

XENON 300MX received FDA 510(k) clearance on 1998-04-03, under 510(k) number K980044.

Who is the listed applicant for XENON 300MX?

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

What is the FDA product code for XENON 300MX?

The FDA product code for XENON 300MX is FSS.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Perkinelmer Optoelectronics 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.

K912354OLYMOUS XLS XENON LIGHT SOURCE

Related Devices (Code: FSS)

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.

K091246ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)Trumpf Medizin Systeme GmbH + Co. KGK003489NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8Medical Illumination International, Inc.K984124AESCULAP XENON LIGHT SOURCEAesculap, Inc.K981962CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCECuda Products Co.K981821VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATORAngiolaz, Inc.K981469CERMAX300 LIGHTSOURCECuda Products Co.

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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