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FDA 510(k)

NIOBI-X RADIATION REDUCTION FILTER

K-Number: K882939 · 1988-11-04

ApplicantAmerican Canadian Products, Inc.
Decision Date1988-11-04
Product CodeITY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NIOBI-X RADIATION REDUCTION FILTER is the device name listed in this FDA 510(k) record. The listed applicant is American Canadian Products, Inc.. It received FDA 510(k) clearance on 1988-11-04 under 510(k) number K882939. 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 NIOBI-X RADIATION REDUCTION FILTER?

NIOBI-X RADIATION REDUCTION FILTER is a medical device that received FDA 510(k) clearance on 1988-11-04. The listed applicant is American Canadian Products, Inc.. The 510(k) number is K882939.

When did NIOBI-X RADIATION REDUCTION FILTER receive FDA 510(k) clearance?

NIOBI-X RADIATION REDUCTION FILTER received FDA 510(k) clearance on 1988-11-04, under 510(k) number K882939.

Who is the listed applicant for NIOBI-X RADIATION REDUCTION FILTER?

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

What is the FDA product code for NIOBI-X RADIATION REDUCTION FILTER?

The FDA product code for NIOBI-X RADIATION REDUCTION FILTER is ITY.

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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

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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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