Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CuattroDR

K-Number: K161937 · 2016-10-06

ApplicantCuattro, LLC
Decision Date2016-10-06
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CuattroDR is a medical device manufactured by Cuattro, LLC. It received FDA 510(k) clearance on 2016-10-06 under approval number K161937. 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 CuattroDR?

CuattroDR is a medical device that received FDA 510(k) clearance on 2016-10-06. It is manufactured by Cuattro, LLC. The 510(k) number is K161937.

When was CuattroDR approved by the FDA?

CuattroDR received FDA 510(k) clearance on 2016-10-06, under approval number K161937.

What company makes CuattroDR?

CuattroDR is manufactured by Cuattro, LLC.

What is the FDA product code for CuattroDR?

The FDA product code for CuattroDR is KPR.

Related Devices (Code: KPR)

K163203Carestream DRX-EvolutionCarestream Health, Inc. K163115GC70Samsung Electronics Co., Ltd. K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd. K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc. K162224ArtPix Mobile EZ2GOCmt Medical Technologies, Ltd. K152294FDR Visionary SuiteShimadzu Corporation

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.

↑