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FDA 510(k)

DDRCOMBI TRAUMA

K-Number: K050718 · 2005-05-26

ApplicantSwissray International, Inc.
Decision Date2005-05-26
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DDRCOMBI TRAUMA is the device name listed in this FDA 510(k) record. The listed applicant is Swissray International, Inc.. It received FDA 510(k) clearance on 2005-05-26 under 510(k) number K050718. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DDRCOMBI TRAUMA?

DDRCOMBI TRAUMA is a medical device that received FDA 510(k) clearance on 2005-05-26. The listed applicant is Swissray International, Inc.. The 510(k) number is K050718.

When did DDRCOMBI TRAUMA receive FDA 510(k) clearance?

DDRCOMBI TRAUMA received FDA 510(k) clearance on 2005-05-26, under 510(k) number K050718.

Who is the listed applicant for DDRCOMBI TRAUMA?

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

What is the FDA product code for DDRCOMBI TRAUMA?

The FDA product code for DDRCOMBI TRAUMA is MQB.

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Other records listing Swissray International, 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.

K070678DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHESTK973710DIGITAL ADD ON MULTI SYSTEM

Related Devices (Code: MQB)

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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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