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FDA 510(k)

INTUITION, MODEL 0170

K-Number: K073632 · 2008-01-10

ApplicantArcoma AB
Decision Date2008-01-10
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTUITION, MODEL 0170 is the device name listed in this FDA 510(k) record. The listed applicant is Arcoma AB. It received FDA 510(k) clearance on 2008-01-10 under 510(k) number K073632. 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 INTUITION, MODEL 0170?

INTUITION, MODEL 0170 is a medical device that received FDA 510(k) clearance on 2008-01-10. The listed applicant is Arcoma AB. The 510(k) number is K073632.

When did INTUITION, MODEL 0170 receive FDA 510(k) clearance?

INTUITION, MODEL 0170 received FDA 510(k) clearance on 2008-01-10, under 510(k) number K073632.

Who is the listed applicant for INTUITION, MODEL 0170?

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

What is the FDA product code for INTUITION, MODEL 0170?

The FDA product code for INTUITION, MODEL 0170 is KPR.

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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

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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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