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FDA 510(k)

BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002

K-Number: K885092 · 1989-03-10

ApplicantMedical Imaging Systems, Inc.
Decision Date1989-03-10
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Imaging Systems, Inc.. It received FDA 510(k) clearance on 1989-03-10 under 510(k) number K885092. The device is classified under product code KPL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002?

BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002 is a medical device that received FDA 510(k) clearance on 1989-03-10. The listed applicant is Medical Imaging Systems, Inc.. The 510(k) number is K885092.

When did BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002 receive FDA 510(k) clearance?

BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002 received FDA 510(k) clearance on 1989-03-10, under 510(k) number K885092.

Who is the listed applicant for BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002?

The FDA 510(k) record lists Medical Imaging Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002?

The FDA product code for BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002 is KPL.

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Related Devices (Code: KPL)

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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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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