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FDA 510(k)

ENDOSCOPIC CO2 REGULATION UNIT UCR

K-Number: K081173 · 2008-12-23

ApplicantOlympus Medical Systems Corporation
Decision Date2008-12-23
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC CO2 REGULATION UNIT UCR 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 2008-12-23 under 510(k) number K081173. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC CO2 REGULATION UNIT UCR?

ENDOSCOPIC CO2 REGULATION UNIT UCR is a medical device that received FDA 510(k) clearance on 2008-12-23. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K081173.

When did ENDOSCOPIC CO2 REGULATION UNIT UCR receive FDA 510(k) clearance?

ENDOSCOPIC CO2 REGULATION UNIT UCR received FDA 510(k) clearance on 2008-12-23, under 510(k) number K081173.

Who is the listed applicant for ENDOSCOPIC CO2 REGULATION UNIT UCR?

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 ENDOSCOPIC CO2 REGULATION UNIT UCR?

The FDA product code for ENDOSCOPIC CO2 REGULATION UNIT UCR is HET.

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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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Related Devices (Code: HET)

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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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