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FDA 510(k)

MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM

K-Number: K913301 · 1991-08-28

ApplicantComet North America, Inc.
Decision Date1991-08-28
Product CodeITY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM is the device name listed in this FDA 510(k) record. The listed applicant is Comet North America, Inc.. It received FDA 510(k) clearance on 1991-08-28 under 510(k) number K913301. The device is classified under product code ITY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM?

MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM is a medical device that received FDA 510(k) clearance on 1991-08-28. The listed applicant is Comet North America, Inc.. The 510(k) number is K913301.

When did MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM receive FDA 510(k) clearance?

MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM received FDA 510(k) clearance on 1991-08-28, under 510(k) number K913301.

Who is the listed applicant for MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM?

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

What is the FDA product code for MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM?

The FDA product code for MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM is ITY.

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.

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Related Devices (Code: ITY)

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.

K000052X-RAY MONOBLOCK, MONOBLOCK XRS-60-330Dynarad Corp.K933162MRX-750Mrx Corp.K923094MOLYBDENUMSoutheastern Medical Diagnostics, Inc.K923141PHILIPS PRE-FILTER OPTIONPhilips Medical Systems, Inc.K921129MRX-700Mrx-Ray Tube Corp.K921130MRX-865Mrx-Ray Tube Corp.

Official Source

View on FDA Database →

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

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