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FDA 510(k)

MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System

K-Number: K193637 · 2020-01-28

Decision Date2020-01-28
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System is the device name listed in this FDA 510(k) record. The listed applicant is Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. It received FDA 510(k) clearance on 2020-01-28 under 510(k) number K193637. 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 MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System?

MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System is a medical device that received FDA 510(k) clearance on 2020-01-28. The listed applicant is Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. The 510(k) number is K193637.

When did MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System receive FDA 510(k) clearance?

MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System received FDA 510(k) clearance on 2020-01-28, under 510(k) number K193637.

Who is the listed applicant for MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System?

The FDA 510(k) record lists Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System?

The FDA product code for MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System is KPR.

Other records listing Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. 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.

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.

Official Source

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