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FDA 510(k)

SEDECAL X PLUS LP PLUS

K-Number: K062335 · 2006-09-14

ApplicantSedecal., Sa.
Decision Date2006-09-14
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SEDECAL X PLUS LP PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2006-09-14 under 510(k) number K062335. 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 SEDECAL X PLUS LP PLUS?

SEDECAL X PLUS LP PLUS is a medical device that received FDA 510(k) clearance on 2006-09-14. The listed applicant is Sedecal., Sa.. The 510(k) number is K062335.

When did SEDECAL X PLUS LP PLUS receive FDA 510(k) clearance?

SEDECAL X PLUS LP PLUS received FDA 510(k) clearance on 2006-09-14, under 510(k) number K062335.

Who is the listed applicant for SEDECAL X PLUS LP PLUS?

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

What is the FDA product code for SEDECAL X PLUS LP PLUS?

The FDA product code for SEDECAL X PLUS LP PLUS is KPR.

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Other records listing Sedecal., Sa. 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.

K232185SM-IVK222951SM-VK221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.K212291PHOENIXK203537Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsK202293Radiographic System Challenge X

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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

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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