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FDA 510(k)

EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I

K-Number: K001241 · 2000-05-09

ApplicantThe Olympus Optical Co.
Decision Date2000-05-09
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I is the device name listed in this FDA 510(k) record. The listed applicant is The Olympus Optical Co.. It received FDA 510(k) clearance on 2000-05-09 under 510(k) number K001241. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I?

EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I is a medical device that received FDA 510(k) clearance on 2000-05-09. The listed applicant is The Olympus Optical Co.. The 510(k) number is K001241.

When did EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I receive FDA 510(k) clearance?

EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I received FDA 510(k) clearance on 2000-05-09, under 510(k) number K001241.

Who is the listed applicant for EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I?

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

What is the FDA product code for EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I?

The FDA product code for EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I is FDF.

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Other records listing The Olympus Optical Co. as applicant

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K032066SONOSURG SYSTEMK030194XUES-41 ENDOSCOPIC ELECTROSURGICAL UNITK021962OLYMPUS ULTRASONIC SURGICAL SYSTEMK023984MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIESK023272DISPOSABLE ASPIRATION NEEDLE NA-200HK023767UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES

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Related Devices (Code: FDF)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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