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FDA 510(k)

SYSTEMS INTEGRATION

K-Number: K102763 · 2011-02-15

ApplicantOlympus Medical Systems Corporation
Decision Date2011-02-15
Product CodeODA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SYSTEMS INTEGRATION is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2011-02-15 under 510(k) number K102763. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEMS INTEGRATION?

SYSTEMS INTEGRATION is a medical device that received FDA 510(k) clearance on 2011-02-15. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K102763.

When did SYSTEMS INTEGRATION receive FDA 510(k) clearance?

SYSTEMS INTEGRATION received FDA 510(k) clearance on 2011-02-15, under 510(k) number K102763.

Who is the listed applicant for SYSTEMS INTEGRATION?

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

What is the FDA product code for SYSTEMS INTEGRATION?

The FDA product code for SYSTEMS INTEGRATION is ODA.

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Other records listing Olympus Medical Systems 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.

K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K260824Gastrointestinal Videoscope Olympus GIF-2T1500K260856Disposable Distal Attachment D-201-13404K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LBK252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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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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