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FDA 510(k)

JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02)

K-Number: K090856 · 2009-05-27

Decision Date2009-05-27
Product CodeING
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) is the device name listed in this FDA 510(k) record. The listed applicant is Thyssenkrupp Ceteco Srl. It received FDA 510(k) clearance on 2009-05-27 under 510(k) number K090856. The device is classified under product code ING. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02)?

JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) is a medical device that received FDA 510(k) clearance on 2009-05-27. The listed applicant is Thyssenkrupp Ceteco Srl. The 510(k) number is K090856.

When did JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) receive FDA 510(k) clearance?

JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) received FDA 510(k) clearance on 2009-05-27, under 510(k) number K090856.

Who is the listed applicant for JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02)?

The FDA 510(k) record lists Thyssenkrupp Ceteco Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02)?

The FDA product code for JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) is ING.

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.

Other records listing Thyssenkrupp Ceteco Srl 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.

Related Devices (Code: ING)

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.

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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