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FDA 510(k)

CTS-3060 AUTOMATED SEMEN ANALYZER

K-Number: K881765 · 1989-02-15

Decision Date1989-02-15
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CTS-3060 AUTOMATED SEMEN ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Motion Analysis Corp.. It received FDA 510(k) clearance on 1989-02-15 under 510(k) number K881765. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CTS-3060 AUTOMATED SEMEN ANALYZER?

CTS-3060 AUTOMATED SEMEN ANALYZER is a medical device that received FDA 510(k) clearance on 1989-02-15. The listed applicant is Motion Analysis Corp.. The 510(k) number is K881765.

When did CTS-3060 AUTOMATED SEMEN ANALYZER receive FDA 510(k) clearance?

CTS-3060 AUTOMATED SEMEN ANALYZER received FDA 510(k) clearance on 1989-02-15, under 510(k) number K881765.

Who is the listed applicant for CTS-3060 AUTOMATED SEMEN ANALYZER?

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

What is the FDA product code for CTS-3060 AUTOMATED SEMEN ANALYZER?

The FDA product code for CTS-3060 AUTOMATED SEMEN ANALYZER is POV.

Related Clinical Trials

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.

Other records listing Motion Analysis Corp. 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.

Related Devices (Code: POV)

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.

Official Source

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