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FDA 510(k)

CSBP-001A BODY ORGAN PERFUSION SYSTEM

K-Number: K081482 · 2008-06-11

ApplicantToshiba America Medical Systems, In.C
Decision Date2008-06-11
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CSBP-001A BODY ORGAN PERFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 2008-06-11 under 510(k) number K081482. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CSBP-001A BODY ORGAN PERFUSION SYSTEM?

CSBP-001A BODY ORGAN PERFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-11. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K081482.

When did CSBP-001A BODY ORGAN PERFUSION SYSTEM receive FDA 510(k) clearance?

CSBP-001A BODY ORGAN PERFUSION SYSTEM received FDA 510(k) clearance on 2008-06-11, under 510(k) number K081482.

Who is the listed applicant for CSBP-001A BODY ORGAN PERFUSION SYSTEM?

The FDA 510(k) record lists Toshiba America Medical Systems, In.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CSBP-001A BODY ORGAN PERFUSION SYSTEM?

The FDA product code for CSBP-001A BODY ORGAN PERFUSION SYSTEM is JAK.

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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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