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FDA 510(k)

PHILIPS EASYDIAGNOST ELEVA

K-Number: K031535 · 2003-06-17

ApplicantPhilips Medical Systems North America Co.
Decision Date2003-06-17
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS EASYDIAGNOST ELEVA is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America Co.. It received FDA 510(k) clearance on 2003-06-17 under 510(k) number K031535. 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 PHILIPS EASYDIAGNOST ELEVA?

PHILIPS EASYDIAGNOST ELEVA is a medical device that received FDA 510(k) clearance on 2003-06-17. The listed applicant is Philips Medical Systems North America Co.. The 510(k) number is K031535.

When did PHILIPS EASYDIAGNOST ELEVA receive FDA 510(k) clearance?

PHILIPS EASYDIAGNOST ELEVA received FDA 510(k) clearance on 2003-06-17, under 510(k) number K031535.

Who is the listed applicant for PHILIPS EASYDIAGNOST ELEVA?

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

What is the FDA product code for PHILIPS EASYDIAGNOST ELEVA?

The FDA product code for PHILIPS EASYDIAGNOST ELEVA is KPR.

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Other records listing Philips Medical Systems North America Co. as applicant

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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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