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FDA 510(k)

CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US

K-Number: K072643 · 2007-11-16

ApplicantOlympus Corporation
Decision Date2007-11-16
Product CodeKZN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corporation. It received FDA 510(k) clearance on 2007-11-16 under 510(k) number K072643. The device is classified under product code KZN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US?

CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US is a medical device that received FDA 510(k) clearance on 2007-11-16. The listed applicant is Olympus Corporation. The 510(k) number is K072643.

When did CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US receive FDA 510(k) clearance?

CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US received FDA 510(k) clearance on 2007-11-16, under 510(k) number K072643.

Who is the listed applicant for CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US?

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

What is the FDA product code for CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US?

The FDA product code for CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US is KZN.

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Other records listing Olympus Corporation 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.

K043128OLYMPUS ENDOARMK042140OLYMPUS BF TYPE UC160-OL8K041494OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2K040940BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM

Related Devices (Code: KZN)

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.

K770667CHROMASCAN TMSterndent 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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