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FDA 510(k)

OLYMOUS XLS XENON LIGHT SOURCE

K-Number: K912354 · 1991-08-16

ApplicantPerkinelmer Optoelectronics
Decision Date1991-08-16
Product CodeGCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMOUS XLS XENON LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Perkinelmer Optoelectronics. It received FDA 510(k) clearance on 1991-08-16 under 510(k) number K912354. The device is classified under product code GCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMOUS XLS XENON LIGHT SOURCE?

OLYMOUS XLS XENON LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 1991-08-16. The listed applicant is Perkinelmer Optoelectronics. The 510(k) number is K912354.

When did OLYMOUS XLS XENON LIGHT SOURCE receive FDA 510(k) clearance?

OLYMOUS XLS XENON LIGHT SOURCE received FDA 510(k) clearance on 1991-08-16, under 510(k) number K912354.

Who is the listed applicant for OLYMOUS XLS XENON LIGHT SOURCE?

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 OLYMOUS XLS XENON LIGHT SOURCE?

The FDA product code for OLYMOUS XLS XENON LIGHT SOURCE is GCT.

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 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.

K980044XENON 300MX

Related Devices (Code: GCT)

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.

K093125ALPHAXENON LIGHT 180 W AND 300 WGimmi GmbHK082925XENON-100 SCB LIGHT SOURCE, MODEL 20132620KARL STORZ Endoscopy-America, Inc.K070376CONMED LINVATEC 300W XENON LIGHT SOURCEConmed LinvatecK040949VIADUCT MINISCOPE AND ACCESSORIESAcueity, Inc.K022490KSEA MEDI PACKKARL STORZ Endoscopy-America, Inc.K031994LINVATEC 300W XENON LIGHT SOURCELinvatec Corp.

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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