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FDA 510(k)

C/T MED-SYSTEMS CASSETTE SYSTEM

K-Number: K980065 · 1998-05-11

Decision Date1998-05-11
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

C/T MED-SYSTEMS CASSETTE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is C/T Med System, Ltd.. It received FDA 510(k) clearance on 1998-05-11 under 510(k) number K980065. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C/T MED-SYSTEMS CASSETTE SYSTEM?

C/T MED-SYSTEMS CASSETTE SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-11. The listed applicant is C/T Med System, Ltd.. The 510(k) number is K980065.

When did C/T MED-SYSTEMS CASSETTE SYSTEM receive FDA 510(k) clearance?

C/T MED-SYSTEMS CASSETTE SYSTEM received FDA 510(k) clearance on 1998-05-11, under 510(k) number K980065.

Who is the listed applicant for C/T MED-SYSTEMS CASSETTE SYSTEM?

The FDA 510(k) record lists C/T Med System, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C/T MED-SYSTEMS CASSETTE SYSTEM?

The FDA product code for C/T MED-SYSTEMS CASSETTE SYSTEM is KCT.

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.

Related Devices (Code: KCT)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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