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FDA 510(k)

IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C

K-Number: K865027 · 1987-02-26

ApplicantCis-Us, Inc.
Decision Date1987-02-26
Product CodeMOT
DecisionSubstantially Equivalent

Device Summary

IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C is the device name listed in this FDA 510(k) record. The listed applicant is Cis-Us, Inc.. It received FDA 510(k) clearance on 1987-02-26 under 510(k) number K865027. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C?

IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C is a medical device that received FDA 510(k) clearance on 1987-02-26. The listed applicant is Cis-Us, Inc.. The 510(k) number is K865027.

When did IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C receive FDA 510(k) clearance?

IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C received FDA 510(k) clearance on 1987-02-26, under 510(k) number K865027.

Who is the listed applicant for IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C?

The FDA 510(k) record lists Cis-Us, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C?

The FDA product code for IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C is MOT.

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Other records listing Cis-Us, 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.

K951708ELSA-HCTK950211ELSA-PTHK890799CURIETRON 192 HIGH DOSE RATEK882449CESIUM 137 SOURCE, MODEL CSM-40K871502PERSONNEL PROTECTIVE SHIELDK863778VENTICIS II

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Related Devices (Code: MOT)

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.

K201177RadGil2R3 X-Ray L.L.CK181737Raycell MK1Best Theratronics LimitedK172087SANGRAYHitachi , Ltd.K161324Raycell Mk2Best Theratronics LimitedK082921RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400Rad Source Technologies, Inc.K051065RAYCELL X-RAY BLOOD IRRADIATORMds Nordion

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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