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FDA 510(k)

CARDIOSCOPE

K-Number: K121266 · 2012-12-11

ApplicantPulsecor Limited
Decision Date2012-12-11
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Pulsecor Limited. It received FDA 510(k) clearance on 2012-12-11 under 510(k) number K121266. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOSCOPE?

CARDIOSCOPE is a medical device that received FDA 510(k) clearance on 2012-12-11. The listed applicant is Pulsecor Limited. The 510(k) number is K121266.

When did CARDIOSCOPE receive FDA 510(k) clearance?

CARDIOSCOPE received FDA 510(k) clearance on 2012-12-11, under 510(k) number K121266.

Who is the listed applicant for CARDIOSCOPE?

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

What is the FDA product code for CARDIOSCOPE?

The FDA product code for CARDIOSCOPE is DXN.

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Related Devices (Code: DXN)

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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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