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FDA 510(k)

DDRELEMENT

K-Number: K110828 · 2011-08-23

ApplicantSwissray Medical AG
Decision Date2011-08-23
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DDRELEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Swissray Medical AG. It received FDA 510(k) clearance on 2011-08-23 under 510(k) number K110828. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DDRELEMENT?

DDRELEMENT is a medical device that received FDA 510(k) clearance on 2011-08-23. The listed applicant is Swissray Medical AG. The 510(k) number is K110828.

When did DDRELEMENT receive FDA 510(k) clearance?

DDRELEMENT received FDA 510(k) clearance on 2011-08-23, under 510(k) number K110828.

Who is the listed applicant for DDRELEMENT?

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

What is the FDA product code for DDRELEMENT?

The FDA product code for DDRELEMENT is KPR.

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Other records listing Swissray Medical AG 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.

K131314DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)K123005DDRVERSA MOTIONK052943DDRFORMULA AND DDRFORMULA PLUS

Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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