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FDA 510(k)

MCI OPTONIX ECONOMY CASSETTE

K-Number: K953444 · 1995-08-02

Decision Date1995-08-02
Product CodeIXA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MCI OPTONIX ECONOMY CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Mci Optonix, Inc.. It received FDA 510(k) clearance on 1995-08-02 under 510(k) number K953444. The device is classified under product code IXA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCI OPTONIX ECONOMY CASSETTE?

MCI OPTONIX ECONOMY CASSETTE is a medical device that received FDA 510(k) clearance on 1995-08-02. The listed applicant is Mci Optonix, Inc.. The 510(k) number is K953444.

When did MCI OPTONIX ECONOMY CASSETTE receive FDA 510(k) clearance?

MCI OPTONIX ECONOMY CASSETTE received FDA 510(k) clearance on 1995-08-02, under 510(k) number K953444.

Who is the listed applicant for MCI OPTONIX ECONOMY CASSETTE?

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

What is the FDA product code for MCI OPTONIX ECONOMY CASSETTE?

The FDA product code for MCI OPTONIX ECONOMY CASSETTE is IXA.

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 Mci Optonix, Inc. 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: IXA)

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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