Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TUBE HOUSING ASSEMBLIES

K-Number: K912338 · 1991-08-07

Decision Date1991-08-07
Product CodeITY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TUBE HOUSING ASSEMBLIES is the device name listed in this FDA 510(k) record. The listed applicant is Comet Ltd. C/O Radiology Resources, Inc.. It received FDA 510(k) clearance on 1991-08-07 under 510(k) number K912338. 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 TUBE HOUSING ASSEMBLIES?

TUBE HOUSING ASSEMBLIES is a medical device that received FDA 510(k) clearance on 1991-08-07. The listed applicant is Comet Ltd. C/O Radiology Resources, Inc.. The 510(k) number is K912338.

When did TUBE HOUSING ASSEMBLIES receive FDA 510(k) clearance?

TUBE HOUSING ASSEMBLIES received FDA 510(k) clearance on 1991-08-07, under 510(k) number K912338.

Who is the listed applicant for TUBE HOUSING ASSEMBLIES?

The FDA 510(k) record lists Comet Ltd. C/O Radiology Resources, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TUBE HOUSING ASSEMBLIES?

The FDA product code for TUBE HOUSING ASSEMBLIES 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.

Other records listing Comet Ltd. C/O Radiology Resources, 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: 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.

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.

↑