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FDA 510(k)

MCI OPTONIX CASSETTE OKAMOTO CASSETE

K-Number: K945039 · 1994-11-22

Decision Date1994-11-22
Product CodeIXA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MCI OPTONIX CASSETTE OKAMOTO CASSETE 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 1994-11-22 under 510(k) number K945039. 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 CASSETTE OKAMOTO CASSETE?

MCI OPTONIX CASSETTE OKAMOTO CASSETE is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Mci Optonix, Inc.. The 510(k) number is K945039.

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

MCI OPTONIX CASSETTE OKAMOTO CASSETE received FDA 510(k) clearance on 1994-11-22, under 510(k) number K945039.

Who is the listed applicant for MCI OPTONIX CASSETTE OKAMOTO CASSETE?

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 CASSETTE OKAMOTO CASSETE?

The FDA product code for MCI OPTONIX CASSETTE OKAMOTO CASSETE 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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