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FDA 510(k)

MULTIDIAGNOST ELEVA

K-Number: K050151 · 2005-02-09

ApplicantPhilips Medical Systems North America, Inc.
Decision Date2005-02-09
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MULTIDIAGNOST ELEVA is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America, Inc.. It received FDA 510(k) clearance on 2005-02-09 under 510(k) number K050151. 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 MULTIDIAGNOST ELEVA?

MULTIDIAGNOST ELEVA is a medical device that received FDA 510(k) clearance on 2005-02-09. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K050151.

When did MULTIDIAGNOST ELEVA receive FDA 510(k) clearance?

MULTIDIAGNOST ELEVA received FDA 510(k) clearance on 2005-02-09, under 510(k) number K050151.

Who is the listed applicant for MULTIDIAGNOST ELEVA?

The FDA 510(k) record lists Philips Medical Systems North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIDIAGNOST ELEVA?

The FDA product code for MULTIDIAGNOST ELEVA is KPR.

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Other records listing Philips Medical Systems North America, 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.

K102005ALLURA XPER OR TABLE SERIESK062233HEARTSTART MRX MONITOR/DEFIBRILLATORK062283THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORSK061052THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90K042867PHILIPS ORTHOPAEDIC APPLICATIONSK041602PANORAMA 1.0T

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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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