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FDA 510(k)

MS-2000

K-Number: K961144 · 1997-03-12

Decision Date1997-03-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MS-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Touritu Engineering Co., Inc.. It received FDA 510(k) clearance on 1997-03-12 under 510(k) number K961144. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MS-2000?

MS-2000 is a medical device that received FDA 510(k) clearance on 1997-03-12. The listed applicant is Touritu Engineering Co., Inc.. The 510(k) number is K961144.

When did MS-2000 receive FDA 510(k) clearance?

MS-2000 received FDA 510(k) clearance on 1997-03-12, under 510(k) number K961144.

Who is the listed applicant for MS-2000?

The FDA 510(k) record lists Touritu Engineering Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MS-2000?

The FDA product code for MS-2000 is DXN.

Related Devices (Code: DXN)

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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