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FDA 510(k)

X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110

K-Number: K910308 · 1991-03-27

ApplicantInmark Corp.
Decision Date1991-03-27
Product CodeITY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 is the device name listed in this FDA 510(k) record. The listed applicant is Inmark Corp.. It received FDA 510(k) clearance on 1991-03-27 under 510(k) number K910308. 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 X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110?

X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 is a medical device that received FDA 510(k) clearance on 1991-03-27. The listed applicant is Inmark Corp.. The 510(k) number is K910308.

When did X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 receive FDA 510(k) clearance?

X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 received FDA 510(k) clearance on 1991-03-27, under 510(k) number K910308.

Who is the listed applicant for X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110?

The FDA 510(k) record lists Inmark Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110?

The FDA product code for X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 is ITY.

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Other records listing Inmark Corp. 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.

K910276X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51K894742RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUSK894413X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS

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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