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FDA 510(k)

AUTOMATED ENDOSCOPE LEAK TESTER

K-Number: K123704 · 2013-02-04

ApplicantOlympus Medical Systems Corp.
Decision Date2013-02-04
Product CodePCV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTOMATED ENDOSCOPE LEAK TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2013-02-04 under 510(k) number K123704. The device is classified under product code PCV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED ENDOSCOPE LEAK TESTER?

AUTOMATED ENDOSCOPE LEAK TESTER is a medical device that received FDA 510(k) clearance on 2013-02-04. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K123704.

When did AUTOMATED ENDOSCOPE LEAK TESTER receive FDA 510(k) clearance?

AUTOMATED ENDOSCOPE LEAK TESTER received FDA 510(k) clearance on 2013-02-04, under 510(k) number K123704.

Who is the listed applicant for AUTOMATED ENDOSCOPE LEAK TESTER?

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

What is the FDA product code for AUTOMATED ENDOSCOPE LEAK TESTER?

The FDA product code for AUTOMATED ENDOSCOPE LEAK TESTER is PCV.

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Other records listing Olympus Medical Systems Corp. as applicant

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Related Devices (Code: PCV)

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.

K212201PENTAX Medical Auto Leakage Tester SHA-P6Pentax of America, Inc.

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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