FDA 510(k)

C.CAM-AC

K-Number: K051460 · 2005-06-15

ApplicantDanish Diagnostic Development A/S

Decision Date2005-06-15

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

C.CAM-AC is the device name listed in this FDA 510(k) record. The listed applicant is Danish Diagnostic Development A/S. It received FDA 510(k) clearance on 2005-06-15 under 510(k) number K051460. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C.CAM-AC?

C.CAM-AC is a medical device that received FDA 510(k) clearance on 2005-06-15. The listed applicant is Danish Diagnostic Development A/S. The 510(k) number is K051460.

When did C.CAM-AC receive FDA 510(k) clearance?

C.CAM-AC received FDA 510(k) clearance on 2005-06-15, under 510(k) number K051460.

Who is the listed applicant for C.CAM-AC?

The FDA 510(k) record lists Danish Diagnostic Development A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C.CAM-AC?

The FDA product code for C.CAM-AC is KPS.

Other records listing Danish Diagnostic Development A/S 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.

K081829CAPIMAGE K040616CARDIOMD-AC K031825C.CAM K011611CARDIOCAM MODEL 9CSY0799 K001888UNICORN MODEL SYS0630

Related Devices (Code: KPS)

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.