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FDA 510(k)

PADSCAN HD SERIES BLADDER SCANNER

K-Number: K131227 · 2013-07-12

ApplicantCarenoso Technology Co., Ltd.
Decision Date2013-07-12
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PADSCAN HD SERIES BLADDER SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Carenoso Technology Co., Ltd.. It received FDA 510(k) clearance on 2013-07-12 under 510(k) number K131227. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PADSCAN HD SERIES BLADDER SCANNER?

PADSCAN HD SERIES BLADDER SCANNER is a medical device that received FDA 510(k) clearance on 2013-07-12. The listed applicant is Carenoso Technology Co., Ltd.. The 510(k) number is K131227.

When did PADSCAN HD SERIES BLADDER SCANNER receive FDA 510(k) clearance?

PADSCAN HD SERIES BLADDER SCANNER received FDA 510(k) clearance on 2013-07-12, under 510(k) number K131227.

Who is the listed applicant for PADSCAN HD SERIES BLADDER SCANNER?

The FDA 510(k) record lists Carenoso Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PADSCAN HD SERIES BLADDER SCANNER?

The FDA product code for PADSCAN HD SERIES BLADDER SCANNER is IYO.

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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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