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FDA 510(k)

BIOMOVE 5000 SYSTEM

K-Number: K080787 · 2008-04-17

ApplicantCuratronic, Ltd.
Decision Date2008-04-17
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIOMOVE 5000 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Curatronic, Ltd.. It received FDA 510(k) clearance on 2008-04-17 under 510(k) number K080787. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMOVE 5000 SYSTEM?

BIOMOVE 5000 SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-17. The listed applicant is Curatronic, Ltd.. The 510(k) number is K080787.

When did BIOMOVE 5000 SYSTEM receive FDA 510(k) clearance?

BIOMOVE 5000 SYSTEM received FDA 510(k) clearance on 2008-04-17, under 510(k) number K080787.

Who is the listed applicant for BIOMOVE 5000 SYSTEM?

The FDA 510(k) record lists Curatronic, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOMOVE 5000 SYSTEM?

The FDA product code for BIOMOVE 5000 SYSTEM is IPF.

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 Curatronic, Ltd. 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.

K042650BIOMOVE 3000

Related Devices (Code: IPF)

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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