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FDA 510(k)

BOLUSPRO ULTRA

K-Number: K002005 · 2000-09-22

ApplicantMarconi Medical Systems, Inc.
Decision Date2000-09-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BOLUSPRO ULTRA is the device name listed in this FDA 510(k) record. The listed applicant is Marconi Medical Systems, Inc.. It received FDA 510(k) clearance on 2000-09-22 under 510(k) number K002005. 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 BOLUSPRO ULTRA?

BOLUSPRO ULTRA is a medical device that received FDA 510(k) clearance on 2000-09-22. The listed applicant is Marconi Medical Systems, Inc.. The 510(k) number is K002005.

When did BOLUSPRO ULTRA receive FDA 510(k) clearance?

BOLUSPRO ULTRA received FDA 510(k) clearance on 2000-09-22, under 510(k) number K002005.

Who is the listed applicant for BOLUSPRO ULTRA?

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

What is the FDA product code for BOLUSPRO ULTRA?

The FDA product code for BOLUSPRO ULTRA is JAK.

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.

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Other records listing Marconi Medical Systems, 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.

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Related Devices (Code: JAK)

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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